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Pharmaceutical Calculations [Hardcover]

B001IGHLSE

Mitchell J. Stoklosa
Mitchell J. Stoklosa (Author)
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B001IGHLTS

(Author), Howard C. Ansel


Howard C. Ansel (Author)
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Editorial Reviews

Product Description
Massachusetts College of Pharmacy and Allied Health Sciences, Boston, Massachusetts. Tenth
edition of a major textbook for pharmacy students. Previous edition 1991. In conformance with
the U.S. Pharmacopeia, uses the metric system instead of the apothecaries' system.
Conversion charts appear in the appendix.

Product Details
• Hardcover: 361 pages
• Publisher: Williams & Wilkins; 10 Sub edition (January
15, 1996)
• Language: English
• ISBN-10: 0683080016
• ISBN-13: 978-0683080018
• Product Dimensions: 9.9 x 6.8 x 1.2 inches
• Shipping Weight: 2 pounds
Pharmaceutical Calculations [Hardcover]
B001IGHLTS

Howard C. Ansel
Howard C. Ansel (Author)
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(Author), Mitchell J. Stoklosa (Author)

Editorial Reviews

Product Description
The gold standard textbook in its area for sixty years,Pharmaceutical Calculations is now in its Twelfth Edition.
Every chapter has been revised and updated to reflect the basic calculations applicable to the contemporary practice of
pharmacy.
This edition provides expanded coverage of enteral and parenteral nutrition. New features include "Calculations
Capsules"--boxed summaries of the type of calculation presented in each chapter, and "A Case in Point"--practical
cases with step-by-step solutions to demonstrate each type of calculation.
Review exercises at the end of the book are completely updated. This edition includes answers to all practice and
review problems.

Product Details
• Hardcover: 464 pages
• Publisher: Lippincott Williams & Wilkins; Twelfth edition
(December 30, 2005)
• Language: English
• ISBN-10: 0781762650
• ISBN-13: 978-0781762656
• Product Dimensions: 10.2 x 7.1 x 0.8 inches

Cleanroom Technology: Fundamentals of


Design, Testing and Operation [Hardcover]
William Whyte (Author)

Editorial Reviews

Review
"...extremely useful and helpful...very well-written, highly organized, easy to understand and
follow..." (Environmental Geology, 2003)

Product Description
A cleanroom is a contamination-controlled environment and is essential in the industrial
manufacture of many electronic, semiconductor, optical, pharmaceutical and medical
products.
The use of cleanrooms for the manufacture of a large range of products such as
microprocessors, CD players, lasers, pharmaceuticals and medical devices continues to grow
and many companies are using cleanrooms for the first time. At the same time, new
technology products that can only be produced in cleanrooms are being developed. This
comprehensive overview of the fundamentals, design, testing and operation of cleanroom
systems provides novices with a introduction to this state-of-the-art technology and
professionals with an accessible reference to the current standards. Readers will benifit from
the author's 35 years of experience in cleanroom technology R&D, consultancy and teaching.
The text is complementary to the structure and content of Whyte's own and many in-house
cleanroom courses in the electronics and pharmaceutical industries.
· Complementary to the highly successful Cleanroom Design, Second Edition and the
forthcoming Cleanroom Testing and Running by the same author
· Presents the fundamentals and latest standards for the design, validation, testing and
running of cleanroom systems
Pitched at introductory level and tailored to fulfil the training requirements of scientists and
engineers new to cleanroom technology See all Editorial Reviews
Product Details

• Hardcover: 320 pages


• Publisher: Wiley (September 12,
2001)
• Language: English
• ISBN-10: 0471868426
• ISBN-13: 978-0471868422
• Product Dimensions: 9.1 x 6.1 x
0.9 inches

SOP Guidelines
D. H. Shah (Author)

Editorial Reviews

Product Description
Introducing the Second Edition of our bestselling book, the new edition is now a comprehensive and
cutting-edge guide to preparation and management of Standard Operating Procedures. It covers the fields
of Production, Quality Control, Quality Assurance, Stores, Engineering, Maintenance and Housekeeping.
Contains actual full text SOPs that can be inorporated directly in your systems and modified as required. It
includes for the first time, detailed and easy to understand methods of developing SOPs that are required
by the manufacturer and regulatory agencies. Electronic SOP management systems and their desired
structures are covered. Also included in the new edition are various systems of Electronic Batch Records
and pharmaceutical ERP systems and their management. CONTENTS Introduction Preface to the1st Edition
DESIGNING EFFECTIVE SOPs Introduction and Purpose of SOPs Benefits of SOPs Types of SOPs Contents of
a Typical SOP Level of Detail Writing Style SOP Development Create/Edit Review Approve Publish
Distribute Archive SOP Format Title Page Table of Contents Text Transition to Electronic SOPs Too Many
Documents Over-complex Documents Inappropriate Format Management Systems Advantages of
Electronic SOPs System Requirements Structure of eSOP System Audit Critical Activities Authenticate Users
Keep Track of Who Has Seen What Validation Support Future of eSOP ELECTRONIC MANUFACTURING
eMANUFACTURING Understanding the e in the eManufacturing Electronic Records Requirements for
Electronic Records Risk Based Approach to Future Purpose of eManufacturing Introduction to Electronic
Batch Records (EBR) Benefits of Electronic Batch Records (EBR) Plant Efficiencies Impact of QC Lab on
Batch Cycle Time Management of Manufacturing Data User Requirement Specification (URS) Vendor
Selection Qualification and Validation of Software Evolution from Paper to EBR Features of cGMP Compliant
EBR System Process Historian for Management of Manufacturing Data Enterprise Resource Plan
About the Author
D. H. Shah graduated in pharmacy in 1962 and in the last 40 years has been actively associated with
manufacture of all categories of drug formulations. He is presently Technical Director with a few reputed
pharmaceutical companies and is involved in quality assurance and GMP compliance activities. --This text
refers to an out of print or unavailable edition of this title.

Product Details

• Hardcover: 464 pages

• Publisher: Business Horizons; 2nd edition (November


15, 2006)
• Language: English

• ISBN-10: 8190078887

• ISBN-13: 978-8190078887

• Product Dimensions: 9.6 x 7.4 x 1.3 inches

Pharmaceutical Equipment Validation:


The Ultimate Qualification Guidebook
[Hardcover]

Phil Cloud (Author)

Editorial Reviews

Product Description
While FDA regulations, cGMP, GLP, GCP, and the industry standard ISO 9000 require that
documentation be established and followed, they do not provide guidelines on how to produce
that documentation. Pharmaceutical Equipment Validation gives details on how to
demonstrate compliance, what data to use, and how to produce the appropriate
documentation. This book's user-friendly diagrams and other clear graphics illustrate key ideas
throughout each protocol, offering a bird's-eye view of what is coming next-and they quickly
guide you through the equipment validation. The author provides a thorough understanding of
how to prepare, test, and complete equipment qualification protocols. He also explains how to
perform qualification testing and whether to test the equipment for a worst case scenario. No
other book deals exclusively with the key issues of equipment qualification and process
validation for pharmaceutical process equipment-and provides instructions on how to achieve
it. With pragmatic approach, this book includes 38 useful protocol templates, already
completed, that provide instant answers to most protocol writing and testing questions. These
templates cover specific equipment types, such, and provide accurate, industry acceptable
equipment qualification protocols. Step-by-step, they show how to qualify each piece of
equipment, and they provide a check for readers own protocols.

Product Details
• Hardcover: 456 pages
• Publisher: Informa Healthcare; 1 edition (August
31, 1998)
• Language: English
• ISBN-10: 1574910795
• ISBN-13: 978-1574910797

HPLC : Quantitative Analysis of


Pharmaceutical Formulations
P.D. Sethi (Author)

Editorial Reviews

Product Description
1 cardiovascular system. 2 musculoskeletal disorders. 3 antibiotics. 4 central nervous system.
5 alimentary system. 6 respiratory system and antiallergics. 7 preparations for external use. 8
vitamins and miscellaneous.

About the Author


Dr.P.D. Sethi obtained his Ph.D. from madras university, Madras, India. He has been pursuning
his analytical career since last 30 years. All the books authored by him are on practical
application of different analytical techniques for analysis of multi-component drug
formulations. these books are the only kind on the subject. while serving as chairman,
ayurvedic pharmacopoeia of india, Dr. Sethi was instrumental in adopting TLC for finger-print
profiling of medicinal plants for their correct identification. it is often said that library of any
analytical laboratory, pharmaceutical institute and pharma industry is incomplete without
books authored by Dr. Sethi.

Product Details
• Hardcover: 900 pages
• Publisher: CBS Publishers & Distributors (February
15, 2007)
• Language: English
• ISBN-10: 8123913788
• ISBN-13: 978-8123913780

Validation of Pharmaceutical Processes,


3rd Edition [Hardcover]
James P. Agalloco (Editor), Frederick J. Carleton (Editor)

Editorial Reviews

Product Description
Completely revised and updated to reflect the significant advances in pharmaceutical production and
regulatory expectations, this third edition of Validation of Pharmaceutical Processes examines and
blueprints every step of the validation process needed to remain compliant and competitive. The many
chapters added to the prior compilation examine validation and six sigma system design; the preparation
of aseptic and non-aseptic pharmaceutical products; active pharmaceutical ingredient and biotechnology
processes, computerized systems; qualification and cleaning of equipment; analytical methods, calibration
and certification. As the industry's leading source for validation of sterile pharmaceutical processes for
more than 10 years, this greatly expanded is a comprehensive analysis of all of the fundamental elements
of this arena with practical solutions for every pharmaceutical and bio-pharmaceutical production process.

Presenting theoretical knowledge and applied practical considerations, this title

 provides an in-depth discussion of recent advances in sterilization


 identifies obstacles that may be encountered at any stage of the validation program, and suggests the
newest and most advanced solutions

 explores distinctive and specific process steps, and identifies critical process control points to reach
acceptable results

 blends the use of theoretical knowledge with recent technological advancements to achieve applied
practical solutions

Product Details

• Hardcover: 760 pages

• Publisher: Informa Healthcare; 3rd edition (September


25, 2007)
• Language: English

• ISBN-10: 0849370558

• ISBN-13: 978-0849370557

Pharmaceutical Product Development


[Hardcover]
N.K. Jain (Editor)

Editorial Reviews

Product Description
Covers subjects such as oral liquids, tablets, parental products, packaging, and others which
are contributed by pharmacists associated with Indian organizations and laboratories as well
as universities.

Product Details
• Hardcover
• Publisher: CBS Publishers & Distributors (February
15, 2007)
• ISBN-10: 8123913214
• ISBN-13: 978-8123913216
Parenteral Quality Control: Sterility,
Pyrogen, Particulate, and Patkage
Integrity Testing (Drugs and the
Pharmaceutical Sciences) [Hardcover]
Michael K. Akers (Author), Dan Larrimore (Author), Dana Guazzo (Author)

Editorial Reviews

Product Description
Baxter Pharmaceutical Solutions, Bloomington, IN. Text describes the recent advances in the
validation and execution of testing schemes for parenteral control. Emphasizes testing
methodologies for the evaluation of package integrity, finished product contamination, and
sterility. Previous edition: c1993.
Product Details
• Hardcover: 408 pages
• Publisher: Informa Healthcare; 3 edition (November
20, 2002)
• Language: English
• ISBN-10: 0824708857
• ISBN-13: 978-0824708856
• Product Dimensions: 9 x 5.9 x 1 inches

Pharmaceutical Water: System Design,


Operation, and Validation [Hardcover]
B001K8DGJS

William V. Collentro
William V. Collentro (Author)
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Product Description
From chemical and biological purity requirements, to system design and its impact on water
purity, to the requirements and restrictions imposed by the regulators, this book
comprehensively covers the unique water requirements of the pharmaceutical and
biotechnology industries. Beginning with a brief overview of the theory and application of the
technology, William Collentro clarifies the seemingly overwhelming engineering aspects as he
discusses design considerations, operation, maintenance, validation, and regulatory-related
topics bases upon personal experience with more than 400 pharmaceutical and related water
purification systems. His extensive field experience and the numerous case studies recounted
in this book ensure that all relevant aspects of pharmaceutical water technology are
thoroughly explained in a clear, concise style.Features

Product Details
• Hardcover: 694 pages
• Publisher: Informa Healthcare; 1 edition (September
30, 1998)
• Language: English
• ISBN-10: 1574910272
• ISBN-13: 978-1574910278
• Product Dimensions: 10.1 x 7.6 x 2 inches

Handbook of Pharmaceutical Manufacturing


Formulations, Second Edition: (Six-Volume Set)
[Hardcover]
Sarfaraz K. Niazi (Author)

Editorial Reviews

Product Description
An authoritative and practical guide to the art and science of formulating drugs.
With thoroughly revised and expanded content, this Second Edition six-volume set compiles volumes from FDA New Drug
Applications, patent applications, and other sources of generic and proprietary formulations to cover the broad spectrum of issues
concerning drug manufacturing. A must-have collection for pharmaceutical manufacturers, educational institutions, and regulatory
authorities, this set is an excellent platform for drug companies to benchmark their products and for generic companies to formulate
drugs coming off patent. As the largest reference on pharmaceutical formulations, this handbook also provides guidelines on how to
file aNDAs in the shortest possible time, helping pharmaceutical companies to cut costs in the areas of pharmaceutical research and
development. Divided conveniently into two parts—regulatory and manufacturing guidelines, and formulations—each volume in the
set covers:
• cGMP compliance
• pre-approval inspections
• stability and bioequivalence testing
• packaging commodity development
• common difficulties in formulating drugs
• changes to aNDAs

Product Details
• Hardcover: 2094 pages

• Publisher: Informa Healthcare; 2 edition (September


21, 2009)
• Language: English

• ISBN-10: 1420081063

• ISBN-13: 978-1420081060

• Product Dimensions: 16.4 x 12.3 x 8.5 inches

Handbook of Pharmaceutical Excipients


(Rowe, Handbook of Pharmaceutical
Excipients) [Hardcover]
Raymond C. Rowe (Editor), Paul J. Sheskey (Editor), Marian E. Quinn (Editor)

Editorial Reviews

Product Description
"The Handbook of Pharmaceutical Excipients" is internationally recognised as the authoritative source of
information on pharmaceutical excipients. "The Handbook of Pharmaceutical Excipients" is a
comprehensive guide to the uses, properties and safety of pharmaceutical excipients and is an essential
reference for those involved in the development, production, control or regulation of pharmaceutical
preparations. The handbook collects together essential data on the physical properties of excipients as
well as providing information on their safe use and potential toxicity. All monographs are also thoroughly
cross-referenced and indexed to allow their identification by chemical, non-proprietary or trade names.
About the Author
Raymond Rowe and Paul Sheskey are both editors of the previous edition. Rowe in particular is widely
recognised internationally as an expert on pharmaceutical excipients

Product Details

• Hardcover: 888 pages

• Publisher: Pharmaceutical Press; 6 edition (July


31, 2009)
• Language: English

• ISBN-10: 0853697922

• ISBN-13: 978-0853697923

• Product Dimensions: 11 x 8.8 x 1.5 inches

Microbial Contamination Control in


Parenteral Manufacturing (Drugs and the
Pharmaceutical Sciences) [Hardcover]
Kevin Williams (Author)

Editorial Reviews

Review
…will be welcomed by all involved in parenteral manufacturing….the value of this book is much more than
as a guide to contamination control; it is the setting of each chapter within a wider and engaging context
that makes this publication unique.-European Journal of Parenteral and Pharmaceutical Sciences

be welcomed by all involved in parenteral manufacturing….the value of this book is much more than as a
guide to contamination control; it is the setting of each chapter within a wider and engaging context that
makes this publication unique.-European Journal of Parenteral and Pharmaceutical Sciences
Product Description
This reference surveys emerging trends, concepts, and procedures used in the characterization and control
of contaminants; the sterile production of traditional drugs and biologics; the design, construction, and
validation of new parenteral facilities; and the monitoring of clean environments-vividly illustrating the
routes by which products, processes, and manufacturing settings become contaminated through contact
with the air, water, raw materials, and the actions of personnel, as well as the current methods necessary
to successfully preclude contamination.

Product Details

• Hardcover: 760 pages

• Publisher: Informa Healthcare; 1 edition (May 20, 2004)

• Language: English

• ISBN-10: 0824753208

• ISBN-13: 978-0824753207
Product Dimensions: 9 x 6.2 x 1.6 inches

Quantitative Analysis of Drugs in


Pharmaceutical Formulations
[Hardcover]
P.D. Sethi (Author)

Editorial Reviews
Product Description
1 introduction. 2 general requirements, quality assurance and accreditation
of calibration/testing laboratories. 3 good laboratory practices. 4 analytical
procedures and analyst validation. 5 profile of a quality control laboratory for
pharmaceutical units. 6 analgesices and antipyretics. 7 alimentary drugs. 8
antibiotics. 9 anti-inflammatory drugs. 10 bronchospasm relaxants(anti-
asthma). 11 cardiovascular drugs. 12 expectorants and cough suppressants.
13 eye, ear, nasal, preparations. 14 keratolytics and cleansers. 15
rubefacients. 16 sedatives and tranquillisers. 17 topical antifungal and anti-
infective preparations. 18 vitamins, minerals and digestive enzyme
preparation.

About the Author


Dr.P.D. Sethi obtained his Ph.D. from madras university, Madras, India. He
has been pursuning his analytical career since last 30 years. All the books
authored by him are on practical application of different analytical techniques
for analysis of multi-component drug formulations. these books are the only
kind on the subject. while serving as chairman, ayurvedic pharmacopoeia of
india, Dr. Sethi was instrumental in adopting TLC for finger-print profiling of
medicinal plants for their correct identification. it is often said that library of
any analytical laboratory, pharmaceutical institute and pharma industry is
incomplete without books authored by Dr. Sethi.

Product Details

• Hardcover: 692 pages

• Publisher: CBS Publishers & Distributors; 3rd edition (January 1, 2008)

• Language: English

• ISBN-10: 8123905602

• ISBN-13: 978-8123905600
Product Dimensions: 9.6 x 7.4 x 1.7 inches

Good Manufacturing Practices for


Pharmaceuticals: A Plan for Total Quality
Control from Manufacturer (Drugs and the
Pharmaceutical Sciences) [Hardcover]
Sidney Willig (Editor)

Editorial Reviews

Review
"...an invaluable resource." -- Unlisted Drugs

"I am pleased to add this edition to my bookshelf!" -- European Journal of Pharmaceutics and Biopharmaceutics
"…an invaluable text….help[s] any individual or student learn the application of the CGMPs." -- Pharmaceutical
Research

"…excellent in presentation and language….a value to anyone interested in drug manufacture." -- American
Journal of Pharmaceutical Education

Product Description
Temple Univ., Philadelphia, PA. Examines United States law and governmental policy affecting domestic and
multinational pharmaceutical manufacturing. Recommends pragmatic ways to interpret and comply with FDA
Current Good Manufacturing Practice regulation and related criteria. Previous edition: c1997.

Product Details

• Hardcover: 732 pages

• Publisher: Informa Healthcare; 5th edition (November


15, 2000)
• Language: English

• ISBN-10: 0824704258

• ISBN-13: 978-0824704254

• Product Dimensions: 9.1 x 6.3 x 1.6 inches

Quality Rules in Packaging [Paperback]


John Sharp (Author)

Editorial Reviews

Product Description
This newly-revised and specifically American edition of the best-selling original is the perfect
introduction to drug packaging Good Manufacturing Practice (GMP). It is the ideal training resource
for workers recently hired into the pharmaceutical, chemical, biotechnology, and bulk
pharmaceutical industries. The central tool for many corporations' introductory training, retraining,
and reinforcement programs, it covers all the drug packaging GMP concepts required by the US
FDA, the British MCA, and the European GMPs. In a simple, no-nonsense manner, the author
explaining the rationale of GMP and the key role played by workers in the production and
packaging of pure, safe, and quality products. --This text refers to an alternate Paperback edition.

Product Details
• Paperback
• Publisher: Interpharm Pr; Intl edition (June
1992)
• ISBN-10: 9994014072
• ISBN-13: 978-9994014071
• Product Dimensions: 8.8 x 5.8 x 0.5
inches
• Shipping Weight: 1.6 ounces
Pharmaceutical Master Validation Plan:
The Ultimate Guide to FDA, GMP, and
GLP Compliance [Hardcover]
B001JSB3Y4

Syed Imtiaz Haider

Syed Imtiaz Haider (Author)

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Editorial Reviews

Product Description
The Master Validation Plan provides a roadmap to management for on-time start-up of facility operations,
and validation of existing facilities, in compliance with GMP requirements. The lack of a comprehensive
Master Validation Plan and well-documented validation procedures is the main reason that new drug,
medical device, medical equipment, and related product applications are rejected by the FDA. In fact, only
about 2% of the applications submitted by foreign pharmaceutical companies are approved each year.
This thorough guide provides the needed solutions and guidance for both foreign and U.S. companies to
achieve FDA compliance and authorization to market their products in the United States. Pharmaceutical
Master Validation Plan: The Ultimate Guide to FDA, GMP, and GLP Compliance will allow you to more easily
achieve satisfactory inspections, new medical product approval, minimize non-conformance, reduce
rework and rejected lots, and avoid recall lots by developing and managing a Master Validation Plan. The
accompanying CD allows users to input the template plan into their computers and tailor it to incorporate
additional regulatory requirements specific to individual companies worldwide and print the required
documents. Together, the book and CD contain everything required to develop and execute a successful
Master Validation Plan based on FDA guidelines for the pharmaceutical industry, and allows the templates
to be extended to diagnostic products, medical device, medical equipment, and biotech industry products.

Product Details

• Hardcover: 208 pages

• Publisher: Informa Healthcare (December 27, 2001)

• Language: English

• ISBN-10: 1574443305

• ISBN-13: 978-1574443301
Product Dimensions: 8.9 x 6.1 x 0.7 inches

Handbook of Pharmaceutical
Granulation Technology (Drugs and the
Pharmaceutical Sciences) [Hardcover]
Dilip M. Parikh (Editor)

Editorial Reviews

Review
…comprehensive….
… very useful for pharmaceutical professionals.

-IASI Polytechnic Magazine (for previous edition) --This text refers to an alternate Hardcover edition.

Product Description
This practical guide integrates the basic principles and current industrial practices of pharmaceutical
granulation production;discussing state-of-the-art technologies and demonstrating cost-effective
approaches to manufacturing solid-dosage forms with content uniformity and consistent physical
properties while complying with regulatory requirements.

Product Details

• Hardcover: 528 pages

• Publisher: Informa Healthcare (June 17, 1997)

• Language: English

• ISBN-10: 0824798821

• ISBN-13: 978-0824798826

• Product Dimensions: 9.1 x 6.1 x 1.3 inches


Shipping Weight: 1.7 pounds

Pharmaceutical Process Validation: An


International (Drugs and the
Pharmaceutical Sciences) [Hardcover]
Robert A. Nash (Editor), Alfred H. Wachter (Editor)

Editorial Reviews

Product Description
Stevens Institute of Technology, Hoboken, NJ. Details strategies to establish appropriate
validation protocols and conduct process validation assignments, monitor and test specific
manufacturing processes for compliance with design limits, and more.

Product Details
• Hardcover: 776 pages
• Publisher: Informa Healthcare; 3 edition (March
27, 2003)
• Language: English
• ISBN-10: 0824708385
• ISBN-13: 978-0824708382
• Product Dimensions: 9.4 x 6.4 x 1.8 inches

Quality Control of Herbal Drugs [Hardcover]


Pulok K Mukherjee (Author)

Editorial Reviews

Product Description
An exhaustive and comprehensive book available on the subject. It includes information on:

Safety and Toxicity in Herbal Drugs


Ethnobotany in Drug Evaluation
Macro-Morphographical Studies
Development of Standardization Parameters
Phytoconstituents and Their Analysis
Extraction of Herbal Drugs
TLC - Detailed Procedures and Guidelines
HPTLC - Densitometry
Pharmacological Screening of Herbal Drugs
Good Agricultural and Harvesting Practices
Quality Assurance and Stability Testing of Herbal Drugs
Analytical Profiles of Selected Medicinal Plants
Plus Annexed Information
Additional References
Internet Resources for further information
International Associations/Organizations
You Need This Book If You Are :
Grower of medicinal herbs
Wholesaler/Distributor
Manufacturer of Herb Extracts
Manufacturer of Herbal Formulations
Researcher
Academician
Regulatory Affairs Specialist

About the Author


Dr. Pulok K Mukherjee obtained his Ph.D in herbal medicine and is a renowned personalty in the firel of
herbal medicine. He has to his credit over 100 research papers in various international journals and one
patent. He is presently Director, School of Natural Product Studies, Jadavpur University, Kolkata, India

Product Details

• Hardcover: 816 pages

• Publisher: Business Horizons (May


2002)
• ISBN-10: 8190078844

• ISBN-13: 978-8190078849

• Product Dimensions: 9.7 x 7.4 x 1.7


inches

The Pharmaceutical Codex: Principles


and Practice of Pharmaceutics (British
Pharmaceutical Codex) [Hardcover]
Walter Lund (Editor)

Editorial Reviews

Product Description
This edition of the codex has been revised and incorporates updated material as well as new
subject areas. The codex provides a reference source on all aspects of pharmaceutical science
and technology that are relevant to the development and provision of medicines.

Product Details
• Hardcover: 1117 pages
• Publisher: Pharmaceutical Press; 12 edition
(January 1994)
• Language: English
• ISBN-10: 0853692904
• ISBN-13: 978-0853692904
• Product Dimensions: 12.7 x 8.1 x 2.6 inches
• Shipping Weight: 4.8 pounds
Pharmaceutical Dosage Forms [Hardcover]
B001KI623U

Herbert Lieberman (Editor), Martin Rieger (Editor), Gilbert S. Banker

Gilbert S. Banker (Editor)

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Editorial Reviews

Review
"…highly recommended." -- Pharmaceutical Development and Technology

"…highly valuable... "…manage[s] to nicely combine a historical account with the mandatory
interpretation of governmental regulations. -- Pharmaceutical Development and Technology

Product Description
Stressing the theory involved in formulating suspensions, emulsions, and colloidal drug
products, this Second Edition of a well-received reference test highlights typical formulations,
the avoidance of formulation pitfalls, and compliance with established regulatory principles.

Product Details
• Hardcover: 552 pages
• Publisher: Informa Healthcare; 2 edition (May
16, 1996)
• Language: English
• ISBN-10: 0824793870
• ISBN-13: 978-0824793876
• Product Dimensions: 10.1 x 7.1 x 1.2 inches

British Herbal Pharmacopoeia [Hardcover]


British Herbal Medicine Association (Author)

Product Details
• Hardcover: 212 pages
• Publisher: British Herbal Medicine Association (December 31, 1996)
• ISBN-10: 0903032104
• ISBN-13: 978-0903032100
• Product Dimensions: 9.7 x 7 x 0.8 inches
• Shipping Weight: 1.6 pounds
Pharmaceutical Dosage Forms: Tablets,
Third Edition (Three-Volume Set) [Hardcover]
Larry L. Augsburger (Editor), Stephen W. Hoag (Editor)

Product Description
The ultimate goal of drug product development is to design a system that maximizes the
therapeutic potential of the drug substance and facilitates its access to patients.
Pharmaceutical Dosage Forms: Tablets, Third Edition is a comprehensive resource of
the design, formulation, manufacture, and evaluation of the tablet dosage form, and with over
700 illustrations it guides pharmaceutical scientists and engineers through difficult and
technical procedures in a simple easy-to-follow format.

New to the third edition:

Product Details
• Hardcover: 1616 pages
• Publisher: Informa Healthcare; 1 edition (June
3, 2008)
• Language: English
• ISBN-10: 1420063456
• ISBN-13: 978-1420063455
• Product Dimensions: 10.9 x 8 x 4.5 inches
• Shipping Weight: 7.4 pounds
Pharmaceutical Dosage Forms Tablets -
2nd Edition [Hardcover]
HALibrman (Author)

Product Details
• Hardcover
• Publisher: Informa Hralthcarr,1990 (1990)
• ASIN: B003ZOPT2W
Pharmaceutical Dosage Forms:
Parenteral Medications, Volume I
(Parenteral Medications, 1) [Hardcover]

Kenneth E. Avis (Editor),

Editorial Reviews

Review
This book forms part of a 3-volume set which is a standard reference work for the formulation and
manufacture of parenteral dosage forms. . . . . .coverage. . .is very comprehensive. . . . . .The entire series
is probably the best source for information of the disparate multidisciplinary area we call pharmaceutics,
and is essential reading for all in this area.
---Journal of Pharmacy and Pharmacology
. . .Every chapter has been revised and updated to keep pace with advances in science and technology.
The editors did a good job of systematically organizing the contents of the text into three volumes. . .The
first volume deals with performultion, formulation, and product development. . . .well illustrated with
photographs, diagrams, and flow charts. . .The contributing authors. . .have impressive credentials and
their views and experiences enhance the value of the book. . .strongly recommend[ed]. . .for both students
and professionals, both in academics and in industry.
---BioPharm

Product Description
University of Tennessee, Memphis. Revised and expanded edition of an in-depth text on parenteral
medications, for graduate and undergraduate students, and industrial or hospital pharmacists. To be
completed in three volumes. Content for all volumes given in Volume 1. DNLM: Infusions.

Product Details

• Hardcover: 580 pages

• Publisher: Marcel Dekker; 2nd, Revised and Expanded edition (January 15, 1992)

• Language: English

• ISBN-10: 0824785762

• ISBN-13: 978-0824785765
Product Dimensions: 10.1 x 6.9 x 1.3 inches


The Theory and Practice of Industrial
Pharmacy [Hardcover]
Leon Lachman

Product Details
• Hardcover: 902 pages
• Publisher: Lea & Febiger; 3 Sub edition (August 1986)
• Language: English
• ISBN-10: 0812109775
• ISBN-13: 978-0812109771

European Customs Inventory of


Chemical Substances: A Guide to the
Classification of Chemicals in the
Combined Nomenclature: Vol 1 [Import]
[Paperback]
European Communities (Author)
Product Details
• Paperback: 1213 pages
• Publisher: European Communities / Union (EUR-OP/OOPEC/OPOCE); 1997 Ed edition
(January 1998)
• ISBN-10: 9282806375
• ISBN-13: 978-9282806371
• Shipping Weight: 1.1 pounds

SOP Guidelines [Hardcover]


D. H. Shah (Author)
Editorial Reviews

Product Description
Introducing the Second Edition of our bestselling book, the new edition is now a comprehensive and
cutting-edge guide to preparation and management of Standard Operating Procedures. It covers the fields
of Production, Quality Control, Quality Assurance, Stores, Engineering, Maintenance and Housekeeping.
Contains actual full text SOPs that can be inorporated directly in your systems and modified as required. It
includes for the first time, detailed and easy to understand methods of developing SOPs that are required
by the manufacturer and regulatory agencies. Electronic SOP management systems and their desired
structures are covered. Also included in the new edition are various systems of Electronic Batch Records
and pharmaceutical ERP systems and their management. CONTENTS Introduction Preface to the1st Edition
DESIGNING EFFECTIVE SOPs Introduction and Purpose of SOPs Benefits of SOPs Types of SOPs Contents of
a Typical SOP Level of Detail Writing Style SOP Development Create/Edit Review Approve Publish
Distribute Archive SOP Format Title Page Table of Contents Text Transition to Electronic SOPs Too Many
Documents Over-complex Documents Inappropriate Format Management Systems Advantages of
Electronic SOPs System Requirements Structure of eSOP System Audit Critical Activities Authenticate Users
Keep Track of Who Has Seen What Validation Support Future of eSOP ELECTRONIC MANUFACTURING
eMANUFACTURING Understanding the e in the eManufacturing Electronic Records Requirements for
Electronic Records Risk Based Approach to Future Purpose of eManufacturing Introduction to Electronic
Batch Records (EBR) Benefits of Electronic Batch Records (EBR) Plant Efficiencies Impact of QC Lab on
Batch Cycle Time Management of Manufacturing Data User Requirement Specification (URS) Vendor
Selection Qualification and Validation of Software Evolution from Paper to EBR Features of cGMP Compliant
EBR System Process Historian for Management of Manufacturing Data Enterprise Resource Plan

About the Author


D. H. Shah graduated in pharmacy in 1962 and in the last 40 years has been actively associated with
manufacture of all categories of drug formulations. He is presently Technical Director with a few reputed
pharmaceutical companies and is involved in quality assurance and GMP compliance activities. --This text
refers to an out of print or unavailable edition of this title.

Product Details

• Hardcover: 464 pages

• Publisher: Business Horizons; 2nd edition (November


15, 2006)
• Language: English

• ISBN-10: 8190078887

• ISBN-13: 978-8190078887

• Product Dimensions: 9.6 x 7.4 x 1.3 inches


Pharmaceutical Facility Management
[Hardcover]
J P S Kohli (Author)

Editorial Reviews

Product Description
Business entities have come to realize that maintaining a well-managed and highly efficient
facility is critical to success. New technologies, security issues and health concerns also have
had a major impact on the importance of, and need for, facility professionals in organizations.
Plant managers must therefore be equipped with a tremendous amount of knowledge and the
ability to cope with and solve a multitude of complex problems and challenges. The current
climate of increased inspections and scrutiny from the regulatory authorities on
manufacturing, combined with the uncertainty of the equity markets, has elevated GMP
compliance to a long-term business strategy. This unique book covers the often overlooked
field of pharmaceutical facility management. In a running pharmaceutical plant, the plant
manager often has to manage a wide range of activities including production, machine
maintenance, building maintenance, training of personnel, validation programs, environmental
monitoring and last but not the least – managing regulatory inspections. This wide spectrum of
activities entails the involvement of people from production, quality control, engineering,
quality assurance, housekeeping etc. thus demanding a lot of time and efforts from the plant
manager to effectively synchronize all these activities. This book will help in designing and
implementing all these required activities and help in streamlining the total functioning of a
pharmaceutical facility. This is a must-have book that all plant mangers and others involved
with a pharmaceutical manufacturing facility should have on their tables for ready reference.

About the Author


J. P. S. Kohli is a pharmacy graduate from University of Delhi followed by Diploma in
Management of Technology Transfer, Patents and Information Systems. He has wide ranging
experience in the pharmaceutical industry, having worked in a pharmaceutical engineering
company followed by working in a pharmaceutical manufacturing facility as Manager-Projects
and Exports. He later set up his own pharmaceutical engineering company providing technical
audit services and engineering consultancy to pharmaceutical companies for all dosage forms
like Tablets, Capsules, Dry Syrups, Liquid Orals, Ointments and Injectables.
Product Details
• Hardcover: 328 pages
• Publisher: Business Horizons (May
2005)
• ISBN-10: 8190078860
• ISBN-13: 978-8190078863
• Product Dimensions: 9.3 x 7.2 x
0.9 inches

Principles & Practice Contamination

Control & Cleanrooms [Hardcover]

Product Details
• Hardcover
• Publisher: Pharma Book Syndicate (January 1, 2003)
• ISBN-10: 8188449040
• ISBN-13: 978-8188449040

QA Manual [Hardcover]
D. H. Shah (Author)
Editorial Reviews

Product Description
This is a comprehensive and detailed guide to management of Quality Assurance in pharmaceutical
production facilities.

It includes
Facility Design
Equipment
Production Controls
Bulk Pharmaceutical Chemicals
Laboratory Controls
Personnel
Validation
Documentation
Audits
A manufacturer must, in designing, making and marketing a medicine, satisfy the regulatory authorities and himself that his products
are of adequate quality, safety and efficacy. Application of the principles of quality assurance and of good manufacturing surveillance,
all contribute to the assurance of quality. The purpose of this book therefore is to provide an instant knowledge-base of such systems
and procedures which will help a pharmaceutical manufacturer to comply with most countries legislation's with regard to quality
assurance and cGMP requirements.

About the Author


D. H. Shah graduated in pharmacy in 1962 and in the last 40 years has been actively associated with
manufacture of all categories of drug formulations. He is presently Technical Director with a few reputed
pharmaceutical companies and is involved in quality assurance and GMP compliance activities.

Product Details

• Hardcover: 312 pages

• Publisher: Business Horizons (May


2002)
• ISBN-10: 8190078828

• ISBN-13: 978-8190078825

• Product Dimensions: 9.4 x 7.1 x 0.8


inches

Rules and Guidance for Pharmaceutical


Manufacturers and Distributors 2007:
aka the Orange Guide [Paperback]
MHRA (Editor)

Editorial Reviews

Product Description
Familiarly known as the "Orange Guide," this title combines the major pharmaceutical Regulations,
Directives and guidance, which wholesalers and the pharmaceutical industry use as their main source
when manufacturing and distributing medicinal products in the EU.

Product Details

• Paperback: 430 pages

• Publisher: Pharmaceutical Press; 1 edition (February


28, 2007)
• Language: English

• ISBN-10: 0853697191

• ISBN-13: 978-0853697190
• Product Dimensions: 9.4 x 6.8 x 0.9 inches

Good Manufacturing Practices and


Inspection (Quality Assurance of
Pharmaceuticals) [Paperback]
World Health Organization (Author)
Editorial Reviews

Product Description
Quality assurance of pharmaceutical products is a continuing concern of WHO. Despite efforts made
around the world to ensure a supply of quality and effective medicines, substandard, spurious and
counterfeit products still compromise health care delivery in many countries. To respond to the global
need for adequate quality assurance of pharmaceuticals, WHO's Expert Committee on Specifications for
Pharmaceutical Preparations has over the years made numerous recommendations to establish standards
and guidelines and to promote the effective functioning of national regulatory and control systems and the
implementation of internationally agreed standards by trained personnel. Many of the relevant documents
endorsed by the Committee are reproduced in this volume, providing guidance covering all aspects of
good manufacturing practices (GMP). Important texts on inspection are also included. Most of the material
has been published separately in the Expert Committee's reports. This compendium brings it together to
make it more accessible and of greater practical value to those working in faculties of pharmacy, in
medicines regulation and control, and in the pharmaceutical industry.

About the Author


UNAIDS

Product Details

• Paperback: 413 pages

• Publisher: World Health Organization; 2 Updated edition


(June 6, 2007)
• Language: English

• ISBN-10: 9241547081

• ISBN-13: 978-9241547086

• Product Dimensions: 9.4 x 6.2 x 1 inches

Drug Formulations Manual


D.P.S. Kohli and D.H. Shah, Eastern Publishers, 2005, Third Edition, 534 p, figs, tables
From the preface: "The third edition enlists 420 drug formulations and manufacturing processes. Some of
the 39 new formulations now included are: Acarbose tablets, Glimepiride and pioglitazone hydrochloride
tablets, Metformin and glipizide tablets, Atorvastatin tablets, Clopidogrel tablets, Nabumetrone tablets,
Fexofenadine tablets, Riserpridone tablets, Gatifloxacin tablets, Gabapentin capsules, Nicerbium tablets,
Rampril capsules and 27 more formulations."

Quality Assurance in Spices And Spice


Products ; Modern of Analysis
Product Details
• Unknown Binding
• Publisher: Allied Publishers Pvt. Ltd. (1999)

• ISBN-10: 817023896X

• ISBN-13: 978-8170238966

Clarke's Analysis of Drugs and Poisons,


Third Edition [Hardcover]
Anthony C. Moffat (Editor)
Editorial Reviews

Product Description
Univ. of London, UK. Reference guide provides analytical data for drugs and poisons. First volume details
analytical toxicology techniques and the second volume deals with the applications of toxicology
techniques in a wide variety of settings. Features more than 1,730 monographs. Previous edition: c1986,
was titled Clarke's Isolation and Identification of Drugs.

Product Details

• Hardcover: 1248 pages

• Publisher: Pharmaceutical Press; 3 edition (February


29, 2004)
• Language: English

• ISBN-10: 0853694737

• ISBN-13: 978-0853694731

• Product Dimensions: 11.6 x 9.3 x 4.1 inches

Facility Validation: Theory, Practice, and


Tools
B001KIDDBO

Graham C. Wrigley

Graham C. Wrigley (Author)

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Editorial Reviews

Product Description
Focusing on validation issues specific to the start-up of a new or upgraded manufacturing facility, this book
provide definitions of the policies, guidelines, and regulations relating to Good Manufacturing Practices
(GMPs) in pharmaceutical industries worldwide. The author discusses the validation concepts, definitions,
and terminology associated with GMPs and details the philosophy and key principles of validation. He
demonstrates how to set up an infrastructure for implementing a validation program. Included in the book
are practical examples of validation documents and SOPs, a comprehensive glossary of validation
terminology, and best practices for evaluating validation programs.

Product Details

• Hardcover: 160 pages

• Publisher: Informa Healthcare; 1 edition (March


29, 2004)
• Language: English

• ISBN-10: 0849323401

• ISBN-13: 978-0849323409

• Product Dimensions: 9.3 x 6.2 x 0.6 inches

Handbook of Stability Testing in


Pharmaceutical Development:
Regulations, Methodologies, and Best
Practices [Hardcover]
Kim Huynh-Ba (Editor)

Editorial Reviews

Product Description
A COMPREHENSIVE AND PRACTICAL GUIDE TO STABILITY TESTING IN PHARMACEUTICAL DEVELOPMENT
Stability testing is required to demonstrate that a pharmaceutical product meets its acceptance criteria throughout its shelf life and to
gain regulatory approval for commercialization. Assessing drug product stability and safety can be quite complicated, and stability
profile can impact many functional areas, including analytical testing, formulation development, toxicology, quality, and regulatory
affairs.
Handbook of Stability Testing in Pharmaceutical Development: Regulations, Methodologies, and Best Practices is the first volume to
cover all aspects of stability testing in pharmaceutical development. It presents a scientific understanding of regulations and balances
methodologies and best practices. Comprising 17 chapters, it provides a wealth of resources for pharmaceutical companies,
educational institutions, and manufacturing laboratories to use as either a supplementary text for stability training courses or as a
reference book for pharmaceutical practitioners.
Topics covered include:
• Latest regulations for stability testing, including cGMP requirements, ICH guidelines, and global
guidances from WHO, ASEAN, EMRO, and other regions.
• Post-approval considerations and regulatory filing strategies to support a global supply chain.
• Methodologies, including development of a stability-indicating method, method validation, and
transfer. This book also discusses physical stability, non-chromatographic methodologies, and
spectroscopic applications.
• Setting specifications, monitoring impurities, and establishing shelf-life of pharmaceutical
products.
• Data management, including stability reports, CMC, and discussion of out-of-specification (OOS)
and out-of-trend (OOT).
• USP-NF testing in support of stability.
• Current industry best practices on stability operation, validation, and calibration of stability
chambers including considerations for photo-stability testing.
• Discussion of matrixing and bracketing to support reduced stability testing.
• Overview of stability programs for biologics and drug-in-devices pharmaceutical products.
This collective work was written by a group of prominent international experts, who have been directly responsible for instituting
industry best practices and establishing the current stability guidelines.

About the Author


Kim Huynh-Ba is Technical Director of Pharmalytik. She has over 20 years of experiences in various analytical areas of
pharmaceutical development, especially in Stability Sciences. She has involved with several projects harmonizing or optimizing
analytical best practices in several companies, including those are under Consent Decree. Ms. Huynh-Ba has authored numerous
technical publications and book chapters. She is a frequent invited speaker at national and international conferences. She has
conducted several training courses on stability compliance and quality issues for American Chemical Society, American Association
of Pharmaceutical Scientists, Pharmaceutical Training Institute, Eastern Analytical Symposium since 2001. She is the founder of
AAPS Stability Focus Group and actively involved with Pharmaceutical Stability Discussion Group. She is an active member of ACS,
AAPS, PSDG, ASQ, POMA and serves in the Governing Board of Eastern Analytical Symposium (EAS).
In my professional career as a pharmaceutical scientist, I have been involved with several aspects of the drug development process
from pre-IND to commercial and, somehow, I usually found myself coming back to a stability related issue. Stability area seems to
draw my utmost interest because in my day-to-day work, my opportunities involved more than one product, and none of the issues
was the same. Each situation posed challenges that usually required an exercise of judgment, an understanding of regulations,
knowledge of science, a grasp of compliance, and an appreciation of common practices.
Since early 2000, I have also been involved with several training opportunities and I struggled to find good, concise, practical
resources, one of which I can just hand to a new scientist who wishes to gain more understanding of stability sciences. In addition, I
encountered the same questions posted over and over on different stability best practices discussion forums.
As a book lover, I also have a good collection of technical books. Unfortunately, most of the stability related books are outdated. In
addition, many of these materials are theoretical and do not contain much practical information. I understand that the pharmaceutical
industry during this period is quite volatile, and guidelines are changing rapidly while regulatory agencies are working closely with the
pharmaceutical industry to accommodate these changes; however, the fundamental information continues to remain quite the same as
current Good Manufacturing Practices (cGMP) continues to be the standard industry practice. Therefore, I hope to assemble a
practical handbook to fill this void.

Product Details

• Hardcover: 389 pages

• Publisher: Springer; 1 edition (November


21, 2008)
• Language: English

• ISBN-10: 0387856269

• ISBN-13: 978-0387856261

• Product Dimensions: 9.3 x 6.2 x 1.1 inches

Validation Standard Operating


Procedures: A Step by Step Guide for
Achieving Compliance in the
Pharmaceutical, Medical [Hardcover]
B001JSB3Y4

Syed Imtiaz Haider

Syed Imtiaz Haider (Author)

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Editorial Reviews

Product Description
One of the most common reasons so many new drug, medical device, or equipment applications are
rejected each year by the FDA is the failure to properly develop and document plans and procedures. This
is required of both U.S. and foreign companies wishing to market their products in the United States. The
lack of well defined validation standard operating procedures may result in adverse FDA findings, recalls,
and heavy financial losses. Key FDA guidelines on good manufacturing practice (GMP), good laboratory
practice (GLP), and validation do not describe exactly how to develop a master validation plan, how to
achieve compliance, or the standard operating procedures and documentation required. This text provides
the required validation standard operating procedures and documentation necessary for achieving
compliance in the pharmaceutical industry. The text and CD are designed to minimize workload and
optimize time, money, and resources. A comprehensive when-and-how-to-do-it guide, Validation Standard
Operating Procedures provides the needed administrative solutions and guidance for achieving compliance
with FDA requirements, and for obtaining authorization to market products in the United States. The CD-
ROM contains 74 template validation standard operating procedures that can be tailored to meet the
regulatory compliance requirements of any pharmaceutical, diagnostic, medical device, medical
equipment, and biotech product. You can edit, print, and customize these procedures to fit your needs.
The book and CD work together to minimize the number of documents used and to ensure their accuracy.
All critical elements and requirements of validation are covered, so you can easily implement them and
avoid the stress that usually accompanies an FDA audit.Features"Provides all the information that
managers need to establish functions, acceptance criteria, and validation procedures in compliance with
FDA guidelines"Includes step-by-step directions for translating GMP requirements into action, based on
your company's Master Validation Plan and execution protocols "Describes how to establish test functions
and prevent defects in order to produce products that are fit for use"Serves as an ideal companion to
Haider's Pharmaceutical Master Validation Plan

About the Author


Haider; Syed Imtiaz Gulf Pharmaceuticals Industries, United Arab Emirates,

Product Details

• Hardcover: 496 pages

• Publisher: Informa Healthcare; 1 edition (December


27, 2001)
• Language: English

• ISBN-10: 1574443313

• ISBN-13: 978-1574443318

• Product Dimensions: 9.5 x 6.3 x 1.3 inches


British Pharmacopoeia 1980: 2v [Hardcover]
Dept.of Health & Social Security (Author)

Product Details

• Hardcover: 1226 pages

• Publisher: Stationery Office Books; 2nd edition (June 1, 1980)

• ISBN-10: 0113206887

• ISBN-13: 978-0113206889

The Pharmacopeia of the United States of America (The United


States pharmacopeia) (1820)
Author: United States Pharmacopoeial Convention
Volume: 1905 8 ed.
Subject: Pharmacopoeias
Publisher: Easton, Pa. [etc.]
Language: English
Call number: AAX-3311
Digitizing sponsor: University of Toronto
Book contributor: Gerstein - University of Toronto
Collection: toronto

Description
Title varies slightly

1820-1975 issued by authority of the United States Pharmacopoeial Convention (1820-90 under various earlier names of the
Convention)

Some revisions have supplements

Supplements issued 1975-79 also cover the National formulary (RS141.2N3)

Continued by the United states pharmacopeia

Analytical Method Validation and


Instrument Performance Verification
[Hardcover]
Tze-Fun Chan (Editor),
Editorial Reviews

Review
“It is a treasure of helpful hints and techniques which can aid even experienced analysts through some of
the ICH procedures.” (Metrohm Information, 4th July 2005)

"While most useful for pharmaceutical laboratories, it may also be useful in certain university and government laboratories." (E-
STREAMS, February 2005)
"…a treasure of helpful hints and techniques that can aid even experienced analysts through some of the ICH procedures." (Inside
Laboratory Management, July/August 2004)
"Given the need for generating reliable analytical data, this book provides practical guidance for validating common and not-so-
common analytical methods and for verifying the performance of instruments…" (Journal of the American Chemical Society, June 9,
2004)
“…a very useful reference text…warmly recommended” (Organic Process Research & Development Journal)

Product Description
Validation describes the procedures used to analyze pharmaceutical products so that the data generated
will comply with the requirements of regulatory bodies of the US, Canada, Europe and Japan. Calibration of
Instruments describes the process of fixing, checking or correcting the graduations of instruments so that
they comply with those regulatory bodies. This book provides a thorough explanation of both the
fundamental and practical aspects of biopharmaceutical and bioanalytical methods validation. It teaches
the proper procedures for using the tools and analysis methods in a regulated lab setting. Readers will
learn the appropriate procedures for calibration of laboratory instrumentation and validation of analytical
methods of analysis. These procedures must be executed properly in all regulated laboratories, including
pharmaceutical and biopharmaceutical laboratories, clinical testing laboratories (hospitals, medical offices)
and in food and cosmetic testing laboratories.

See all Editorial Reviews

Product Details

• Hardcover: 320 pages

• Publisher: Wiley-Interscience; 1 edition (January


28, 2004)
• Language: English

• ISBN-10: 0471259535

• ISBN-13: 978-0471259534

• Product Dimensions: 9.4 x 6.4 x 0.8 inches

Pharmaceutical Analysis [Hardcover]


T. Higuchi (Editor)

Product Details

• Hardcover: 854 pages

• Publisher: John Wiley & Sons Inc (December 1961)

• Language: English

• ISBN-10: 0470395346

• ISBN-13: 978-0470395349

Validation and Qualification in Analytical


Laboratories [Hardcover]
B001JSB7IQ

Ludwig Huber

Ludwig Huber (Author)

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Editorial Reviews

Review
a great single reference containing all you ever wanted to know about validating and verifying assay or
equipment performance.
Doody’s Review - Valerie L. Ng, PhD, MD

Product Description
This Second Edition discusses ways to improve pharmaceutical product quality while achieving
compliance with global regulatory standards. With comprehensive step-by-step instructions, practical
recommendations, standard operating procedures (SOPs), checklists, templates, and graphics for easy
incorporation in a laboratory. This title serves as a complete source to the subject, and explains how to
develop and implement a validation strategy for routine, non-routine, and standard analytical methods,
covering the entire equipment, hardware, and software qualification process. It also provides guidance on
qualification of certified standards, in-house reference materials, and people qualification, as well as
internal and third party laboratory audits and inspections.

Product Details

• Hardcover: 288 pages

• Publisher: Informa Healthcare; 2 edition (July


23, 2007)
• Language: English

• ISBN-10: 084938267X

• ISBN-13: 978-0849382673

• Product Dimensions: 9 x 6.1 x 0.8 inches

British Pharmaceutical Codex 1973


[Hardcover]
Pharmaceutical Society of Great Britain (Author)

Product Details

• Hardcover: 1024 pages

• Publisher: The Pharmaceutical Press (June 1973)

• Language: English

• ISBN-10: 0853690847

• ISBN-13: 978-0853690849

Microbiological Contamination Control


in Pharmaceutical Clean Rooms [Hardcover]
Nigel Halls (Editor)
Editorial Reviews

Review
…Throughout the book one finds concise, practical and helpful chapters and sections. Everything within
the book avoids unnecessary descriptions, but comes to the point underlined by years of experience….

…an excellent practical reference….An enjoyment to read and learn.


-European Journal of Parenteral and Pharmaceutial Sciences

Product Description
This book neatly clarifies some of the perceived problems surrounding contamination control in
pharmaceutical industry clean rooms. It helps manufacturers satisfy both domestic and international
regulations and prevents their companies from suffering the consequences of non-compliance. It includes
up-to-date information on microbiological contamination in sterile manufacturing, microbiological media
fills, microbiological environmental monitoring, control in aqueous-based, non-sterile pharmaceuticals,
rapid testing methods, and clean room contamination control. This book is a must for the microbiologist
working in pharmaceutical manufacturing. INV STAT: Not yet published

Product Details

• Hardcover: 200 pages

• Publisher: CRC Press; 1 edition (June 26,


2004)
• Language: English

• ISBN-10: 0849323002

• ISBN-13: 978-0849323003

• Product Dimensions: 9.5 x 6.4 x 0.7


inches

Troubleshooting HPLC Systems: A Bench


Manual
Paul C. Sadek (Author)
Product Description
A complete, up-to-date guide to the use, maintenance, and troubleshooting of HPLC systems

The last twenty-five years have seen a dramatic rise in the use of High Performance Liquid
Chromatography (HPLC) in laboratories worldwide. Troubleshooting HPLC Systems provides analysts as
well as laboratory technicians and managers with a readily accessible and immensely useful guide to the
new generation of HPLC equipment and techniques. With an emphasis on effective troubleshooting of
HPLC systems, this lab companion covers system configuration and functions, problem-solving procedures,
maintenance, and HPLC basics. It then walks chromatographers investigating the source of a malfunction
through each system component-from solvents and reservoirs to sample preparation to columns and
detectors. Special features of Troubleshooting HPLC Systems include:
* A detailed review of HPLC instrumentation and accessories
* The role of operating parameters as indicators of system performance
* Step-by-step troubleshooting protocols for each system component
* How to set up a preventive maintenance program for HPLC systems
* An overview of the categories of HPLC separations
* A compilation of HPLC terms and definitions
* Tables and charts detailing solvents' properties

See all Editorial Reviews

Product Details

• Spiral-bound: 306 pages

• Publisher: Wiley-Interscience (October 5,


1999)
• Language: English

• ISBN-10: 0471178349

• ISBN-13: 978-0471178347

• Product Dimensions: 9.2 x 6.6 x 1.1


inches

Good Manufacturing Practices for


Pharmaceuticals, Sixth Edition (Drugs
and the Pharmaceutical Sciences) [Hardcover]
Graham Bunn (Author)
Product Description
With global harmonization of regulatory requirements and quality standards and national and global
business consolidations ongoing at a fast pace, pharmaceutical manufacturers, suppliers, contractors, and
distributors are impacted by continual change. Offering a wide assortment of policy and guidance
document references and interpretations, this Sixth Edition is significantly expanded to reflect the increase
of information and changing practices in CGMP regulation and pharmaceutical manufacturing and control
practices worldwide. An essential companion for every pharmaceutical professional, this guide is updated
and expanded by a team of industry experts, each member with extensive experience in industry or
academic settings.

Product Details

• Hardcover: 424 pages

• Publisher: Informa Healthcare; 6 edition (December


26, 2006)
• Language: English

• ISBN-10: 0849339723

• ISBN-13: 978-0849339721

• Product Dimensions: 10.1 x 7 x 1.1 inches

Handbook of Pharmaceutical Analysis by


HPLC, Volume 6 (Separation Science and
Technology) [Hardcover]
Satinder Ahuja (Editor)
Product Description
High pressure liquid chromatography–frequently called high performance liquid chromatography (HPLC or,
LC) is the premier analytical technique in pharmaceutical analysis and is predominantly used in the
pharmaceutical industry. Written by selected experts in their respective fields, the Handbook of
Pharmaceutical Analysis by HPLC Volume 6, provides a complete yet concise reference guide for
utilizing the versatility of HPLC in drug development and quality control. Highlighting novel approaches in
HPLC and the latest developments in hyphenated techniques, the book captures the essence of major
pharmaceutical applications (assays, stability testing, impurity testing, dissolution testing, cleaning
validation, high-throughput screening,

* A complete reference guide to HPLC


* Describes best practices in HPLC and offers 'tricks of the trade' in HPLC operation and method
development
* Reviews key HPLC pharmaceutical applications and highlights currents trends in HPLC ancillary
techniques, sample preparations, and data handling

See all Editorial Reviews

Product Details

• Hardcover: 600 pages

• Publisher: Academic Press; 1 edition (April


12, 2005)
• Language: English

• ISBN-10: 0120885476

• ISBN-13: 978-0120885473

United States Pharmacopoeia 33 -


National Formulary 28
Author:
Unites States Pharmacopoeia Convention

Print Version
The United States Pharmacopoeia 33 - National Formulary 28 (USP 33-NF 28) is a three-volume combination of two official
compendia, the United States Pharmacopoeia (USP) and the National Formulary (NF). USP-NF is an annual publication, comprising
of one main publication and two supplements each year.
In January 2010 USP recalled USP 33-NF 28 and subsequently reissued a revised publication in April 2010. Purchasers of the original
USP 33-NF 28 will have been sent the revised edition called USP 33-NF 28 Reissue. New customers will simply receive the official,
fully revised reissue version.
Customers benefit from:
• Individually bound print copy of USP 33-NF 28 Reissue New and Revised Official Text Since the Second Supplement to
USP 32-NF 27
• Individually bound print copy of First Supplement to the USP 33-NF 28 Reissue

• Individually bound PRINT copy of Second Supplement to the USP 33-NF 28 Reissue (June 2010) Designed to fit in
compact storage facilitity which comes with the order.
CD-Rom features:
• USP 32-NF 27 and its supplements
• USP 33-NF 28 Reissue New and Revised Official Text Since the Second Supplement to USP 32-NF 27
• First Supplement to the USP 33-NF 28 Reissue
The USP 33-NF 28 becomes official on 01 May 2010. The First Supplement is available from February 2010 and becomes official on
01 August 2010. The Second Supplement is available from June 2010 and becomes official on 01 December 2010.
The USP-NF provides access to official standards, enforceable by the U.S. Food and Drug Administration for drugs and related
products manufactured and marketed in the United States. In addition, the USP serves as a clear step-by-step guide for the
specifications - tests, procedures, and acceptance criteria - required for pharmaceutical manufacturing and quality control.
USP 33-NF 28 includes more than 4200 monographs for drugs, excipients, biologics and dietary supplements. The monograph design
is in a new easy-to-read format with concise language. Format developments include:
• Tests and procedures clearly designated in a logical flow

• Reorganised content; sub-headings reordered and renamed to meet ICH specifications

• Calculations have been expanded to provide more details; added impurity tables and heavy metal units updated to ppm
• Preparation of solutions are abbreviated and a new streamlined format used.
The USP-NF is an essential publication for anyone working in pharmaceuticals, biotechnology, dietary supplements, medical devices
and gases and veterinary drugs and is also is an important reference for pharmacies, libraries, universities, and schools of medicine
and pharmacy.
The print edition of USP-NF is printed on a thick, durable paper stock suitable for laboratory use. The English edition is shipped in a
convenient slipcase for easy access and storage.
The USP-NF is a subscription product, with a fixed subscription period of November 2009 to October 2010.

Key features:
• Official, fully revised reissue
• Compact storage case
• Print and user-friendly CD-ROM combination package
• More than 4,400 monographs
• Over 200 general chapters covering general tests and assays
• A new, easy-to-read format and monograph layout
• Helpful guides and charts that make it easy to find focus-specific information
• Ensures compliance with official standards
• Establishes in-house standard operating procedures and specifications
• Facilitates new product development and approval.

Exten 3 Sub. No 77010


t Volumes . 14

Size tbc Price £752.0


0

Bindi Hardbac Freque Annual


ng k ncy

British Pharmacopoeia 2010 [Hardcover]


Stationery Office (U. k.) (Author)

Product Description
Produced by the British Pharmacopoeia Commission Secretariat, The British Pharmacopoeia (BP) 2010 is
the leading collection of standards for UK medicinal products and pharmaceutical substances. Now used in
almost 100 countries, the BP remains an essential reference for all individuals and organisations working
within pharmaceutical research and development, manufacture, and testing across the globe. Key
Features: Legally effective in the UK from 1 January 2010, 40 new monographs for formulated
preparations, New and revised monographs for Herbal and Complementary Medicines within their own
section in Volume III, Additional standards for widely used unlicensed formulations, and European
Pharmacopoeia 6th edition material up to and including Supplement 6.5. European Pharmacopoeia
monographs are clearly distinguished and cross-referenced while a full index ensures easy access to the
current legally binding UK standards.
Product Details

• Hardcover: 5300 pages

• Publisher: Stationery Office Books (TSO); 1 edition


(August 15, 2009)
• Language: English

• ISBN-10: 0113228287

• ISBN-13: 978-0113228287

European Pharmacopoeia 6.0 [Hardcover]


Council of Europe (Corporate Author)

The 6th edition of the European Pharmacopoeia came into force on 1 January 2008 and consists of a two-volume main edition. It will
be updated on a regular basis with one supplement following in October 2007, three in 2008 and 2009, and the remaining supplement
in 2010 to create a collection of eight non-cumulative supplements.

Key features:
• Over 1,800 specific and general monographs will be published.

• Contains all types of active substances used to prepare pharmaceutical products: various chemical substances, antibiotics,
biological substances, vaccines for human or veterinary use, Immunosera, Radiopharmaceutical preparations, herbal drugs
and homoepahtic preparations.
• Also contains dosage forms, general monographs, materials, containers and sutures.
• Around 268 general methods with figures or chromatograms.
• Over 2210 reagents will be described.
This publication is available in Print, CD-ROM and Pack format. Supplements 6.1, 6.2, and 6.3 are available to buy separately.
Supplements 6.3, 6.4 and 6.5 are also available to buy as a pack, please see below.

Exten 4,392 ISBN 978928716


t pages 0546

Size 215 x Price £259.00


302mm

Bindi Hardback Publish 23 Jul 2007


ng ed

The International Pharmacopoeia


Fourth Edition
Author:

World Health Organization (WHO)

'The International Pharmacopoeia - Fourth Edition' consolidates the texts of the five separate volumes of the third edition. Certain
additions and amendments have been made to the notices in order to clarify the interpretation of the Pharmacopoeia and to facilitate
application of the requirements by the user.
This fourth edition will include all the monographs in the third edition together with new monographs for didanosine, indinavir
sulfate, nelfinavir mesilate, nevirapine, ritonavir, saquinovir, saquinovir mesilate. All the monograph texts are brought together in one
section and the method texts in another. Each of these major sections are divided into appropriate sub-sections and the method texts
are numbered for ease of cross-reference.
Method texts that have been updated include, for example, the text on high performance liquid chromatography [HPLC]. This has
been revised to clarify certain technical terms and to add advice on adjustment of chromatographic conditions, as recommended by the
WHO Expert Committee on Specifications for Pharmaceutical Preparations in October 2004.

Exten 2 Volumes / 1499 ISBN 978924156


t pages 3017

Size 160 x 240mm Price £200.00

Bindi Hardback Publish 28 Feb 2007


ng ed
Martindale: The Complete Drug
Reference, 36th Edition (2 Volume Set)
[Hardcover]
Sean C. Sweetman (Editor)

Product Description
This book provides reliable, unbiased and evaluated information on drugs and medicines used throughout
the world. Each new drug licensed for use has its own potential benefits and adverse effects, and its own
profile for dosage, administration and indications. Furthermore, manufacturers make regular changes to
existing drug names and formulations, which can affect their interactions and safe usage. Health
professionals require the correct answers and need to have confidence in the drugs information they use -
but with medicines evolving at this rate, how can they be sure their knowledge is up to date? "Martindale"
contains up to date information about more than 5,800 substances. Each and every entry is reviewed by
our pharmaceutical editors to ensure health professionals have the most current data. Formulations
change. Definitions change. Names change. But you can always trust "Martindale".

Product Details

• Hardcover: 3694 pages

• Publisher: Pharmaceutical Press; 36 edition (March


16, 2009)
• Language: English

• ISBN-10: 0853698406

• ISBN-13: 978-0853698401

• Product Dimensions: 14.2 x 10 x 5.2 inches


Japanese Pharmacopeia (Pharmacopoeia
of Japan) [Hardcover]
Yakuji Nippo Ltd (Corporate Author)

Product Details

• Hardcover: 1788 pages

• Publisher: Maruzen Company, Ltd.; 15 edition (March 2006)

• Language: English

• ISBN-10: 4840809747

• ISBN-13: 978-4840809740
The Merck Index: An Encyclopedia of
Chemicals, Drugs, and Biologicals [Hardcover]
Maryadele J. O'Neil (Editor)

Product Description
The Merck Index is a one-volume encyclopedia of chemicals, drugs and biologicals that contains more than
10,000 monographs. Each monograph in this authoritative reference source is a concise description of a
single substance or a small group of closely related compounds.

Compounds included:
• human and veterinary drugs
• biotech drugs and monoclonal antibodies
• substances used for medical imaging
• biologicals and natural products
• plants and traditional medicines
• nutraceuticals and cosmeceuticals
• agriculturals, pesticides and herbicides
• Organic chemicals used in research
• Food additives and supplements
• dyes, colors and indicators
• environmentally significant substances
Information provided:
• chemical, common and generic names
• Over 15,000 trademarks and associated companies
• CAS Registry Numbers for over 12,000 compounds
• Over 8,500 chemical structures
• molecular formulae, weights and percentage composition
• capsule statements identifying compound classes and scientific significance
• scientific and patent literature references
• physical and toxicity data
• therapeutic and commercial uses
• caution and hazard information
In addition, there are more than 700 new and completely revised monographs, thousands of new references, trademarks and uses
added to existing monographs. Now includes a companion CD-ROM which features 989 monographs no longer available in print,
organic name reactions, supplemental tables and a new user interface for user-friendly searching.
Features of the CD:
• Searchable by keywords, references, and numerical properties
• Search the complete contents of the 14th edition, plus nearly a thousand monographs archived
from previous editions
• Comes with a free one-year subscription to the Merck Index Internet Edition
• Windows-compatible CD powered by CambridgeSoft's ChemFinder
• Extensively revised supplemental tables now including acronyms, vaccines, and physical
constants
• More than 70 pages of hard to find information in one easy-to-use place

Product Details

• Hardcover: 2564 pages

• Publisher: Merck; 14 edition (November 3,


2006)
• Language: English

• ISBN-10: 091191000X

• ISBN-13: 978-0911910001

Computer Systems Validation: Quality


Assurance, Risk Management, and
Regulatory Compliance for
Pharmaceutical and Health
Publisher: Informa HealthCare | 2003-12-18 | 969 Pages | ISBN: 0849318718 | PDF | 13.6 MB

Both pervasive and ubiquitous, computerized systems are now an integral component of every corporate
strategy in pharmaceutical and healthcare companies. However, when technology is combined with high-
risk public safety projects or the production and control of life-saving medicines or devices, it is necessary
to ensure that it is reliable, quality assured, and validated. The most comprehensive guide on computer
validation currently available, containing more than 200 illustrations and more than 100 tables, Computer
Systems Validation helps you see the big picture.The author reviews regulations and their development,
organization responsibilities, validation life cycle based on GAMP4 Guide, strategic approaches to
validation, electronic records and signatures, handling regulatory inspections, metrics, and opportunities
for performance improvement. He presents practical examples and checklists throughout the book and
explores the role of quality assurance and risk management as key components of pragmatic regulatory
compliance. Covering methods that help you avoid duplicating effort among departments and business
functions, the book demonstrates how you can use your investment in technology to improve business
efficiency and gain the competitive edge.

Method Validation in Pharmaceutical


Analysis: A Guide to Best Practice [Hardcover]
B0034PTP3Q

Joachim Ermer

Joachim Ermer (Editor)

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Product Description
Adopting a practical approach, the authors provide a detailed interpretation of the existing regulations
(GMP, ICH), while also discussing the appropriate calculations, parameters and tests. The book thus allows
readers to validate the analysis of pharmaceutical compounds while complying with both the regulations
as well as the industry demands for robustness and cost effectiveness.

Following an introduction to the basic parameters and tests in pharmaceutical validation, including specificity, linearity, range,
precision, accuracy, detection and quantitation limits, the text focuses on a life-cycle approach to validation and the integration of
validation into the whole analytical quality assurance system. The whole is rounded off with a look at future trends.
With its first-hand knowledge of the industry as well as regulating bodies, this is an invaluable reference for analytical chemists, the
pharmaceutical industry, pharmaceutists, QA officers, and public authorities.
See all Editorial Reviews

Product Details

• Hardcover: 418 pages

• Publisher: Wiley-VCH; 1 edition (May 9,


2005)
• Language: English

• ISBN-10: 3527312552

• ISBN-13: 978-3527312559

• Product Dimensions: 9.6 x 7 x 1 inches

Development and Validation of Analytical


Methods, Volume 3 (Progress in
Pharmaceutical and Biomedical Analysis)
C.M. Riley (Author

Product Description
The need to validate an analytical or bioanalytical method is encountered by analysts in the
pharmaceutical industry on an almost daily basis, because adequately validated methods are a necessity
for approvable regulatory filings. What constitutes a validated method, however, is subject to analyst
interpretation because there is no universally accepted industry practice for assay validation. This book is
intended to serve as a guide to the analyst in terms of the issues and parameters that must be considered
in the development and validation of analytical methods. In addition to the critical issues surrounding
method validation, this book also deals with other related factors such as method development, data
acquisition, automation, cleaning validation and regulatory considerations.

The book is divided into three parts. Part One, comprising two chapters, looks at some of the basic concepts of method validation.
Chapter 1 discusses the general concept of validation and its role in the process of transferring methods from laboratory to laboratory.
Chapter 2 looks at some of the critical parameters included in a validation program and the various statistical treatments given to these
parameters.
Part Two (Chapters 3, 4 and 5) of the book focuses on the regulatory perspective of analytical validation. Chapter 3 discusses in some
detail how validation is treated by various regulatory agencies around the world, including the United States, Canada, the European
Community, Australia and Japan. This chapter also discusses the International Conference on Harmonization (ICH) treatment of assay
validation. Chapters 4 and 5 cover the issues and various perspectives of the recent United States vs. Barr Laboratories Inc. case
involving the retesting of samples.
Part Three (Chapters 6 - 12) covers the development and validation of various analytical components of the pharmaceutical product
development process. This part of the book contains specific chapters dedicated to bulk drug substances and finished products,
dissolution studies, robotics and automated workstations, biotechnology products, biological samples, analytical methods for cleaning
procedures and computer systems and computer-aided validation. Each chapter goes into some detail describing the critical
development and related validation considerations for each topic.
This book is not intended to be a practical description of the analytical validation process, but more of a guide to the critical
parameters and considerations that must be attended to in a pharmaceutical development program. Despite the existence of numerous
guidelines including the recent attempts by the ICH to be implemented in 1998, the practical part of assay validation will always
remain, to a certain extent, a matter of the personal preference of the analyst or company. Nevertheless, this book brings together the
perspectives of several experts having extensive experience in different capacities in the pharmaceutical industry in an attempt to bring
some consistency to analytical method development and validation.

Product Details

• Hardcover: 362 pages

• Publisher: Pergamon; 1 edition (June 12,


1996)
• Language: English

• ISBN-10: 0080427928

• ISBN-13: 978-0080427928

• Product Dimensions: 9 x 6.1 x 1 inches


Computer Applications in
Pharmaceutical Research and
Development (Wiley Series in Drug
Discovery and Development) [Hardcover]
B003BFP2E0

Sean Ekins

Sean Ekins (Editor)

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Product Description
A unique, holistic approach covering all functions and phases of pharmaceutical research and development

While there are a number of texts dedicated to individual aspects of pharmaceutical research and
development, this unique contributed work takes a holistic and integrative approach to the use of
computers in all phases of drug discovery, development, and marketing. It explains how applications are
used at various stages, including bioinformatics, data mining, predicting human response to drugs, and
high-throughput screening. By providing a comprehensive view, the book offers readers a unique
framework and systems perspective from which they can devise strategies to thoroughly exploit the use of
computers in their organizations during all phases of the discovery and development process.

Chapters are organized into the following sections:


* Computers in pharmaceutical research and development: a general overview
* Understanding diseases: mining complex systems for knowledge
* Scientific information handling and enhancing productivity
* Computers in drug discovery
* Computers in preclinical development
* Computers in development decision making, economics, and market analysis
* Computers in clinical development
* Future applications and future development
Each chapter is written by one or more leading experts in the field and carefully edited to ensure a
consistent structure and approach throughout the book. Figures are used extensively to illustrate complex
concepts and multifaceted processes. References are provided in each chapter to enable readers to
continue investigating a particular topic in depth. Finally, tables of software resources are provided in
many of the chapters.

This is essential reading for IT professionals and scientists in the pharmaceutical industry as well as
researchers involved in informatics and ADMET, drug discovery, and technology development. The book's
cross-functional, all-phases approach provides a unique opportunity for a holistic analysis and assessment
of computer applications in pharmaceutics.

See all Editorial Reviews

Product Details

• Hardcover: 817 pages

• Publisher: Wiley-Interscience (June 30,


2006)
• Language: English

• ISBN-10: 0471737798

• ISBN-13: 978-0471737797

SAS Programming in the Pharmaceutical


Industry [Paperback]
B001K8CN9W

Jack Shostak

Jack Shostak (Author)

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Product Description
At last! A real-world reference guide for clinical trial SAS programming, packed with solutions that
programmers can apply to their day-to-day problems. Discover key techniques and tools available within
Base SAS (including the macro language and PROC SQL), SAS/GRAPH, and SAS/STAT that can be used to
resolve many common issues in working with clinical trial data. Organized to reflect the statistical
programmer's work flow, this user-friendly text begins with an introduction to the working environment,
then presents chapters on importing and massaging data into analysis data sets, producing clinical trial
output, and exporting data. Valuable plug-and-play programming examples are provided throughout.
Whether you're a novice seeking an introduction to SAS programming for the pharmaceutical industry or a
junior-level programmer exploring new approaches to problem solving, you'll find a wealth of practical
suggestions to help you sharpen your skills.

See all Editorial Reviews

Product Details

• Paperback: 360 pages

• Publisher: SAS Publishing; 1 edition


(September 2005)
• Language: English

• ISBN-10: 1590477936

• ISBN-13: 978-1590477939

Liquid Interfaces in Chemical, Biological,


and Pharmaceutical Applications
(Surfactant Science Series)

Alfred H. Wachter (Author)


Product Description
A reference describing interfacial phenomena in chemistry, biology, physics and medicine, of liquid
interfaces. Includes more the 700 equations, 430 drawings and photographs, 2,800 references, and
contributions from more than 60 international authors. Complete coverage of surface chemistry and its
applications in a variety of fields.

Product Details

• Hardcover: 888 pages

• Publisher: CRC Press; 1st edition (February


15, 2001)
• Language: English

• ISBN-10: 0824704576

• ISBN-13: 978-0824704575

HPLC Methods for Recently Approved


Pharmaceuticals [Hardcover]
B001H6U7KY

George Lunn

George Lunn (Author)

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Product Description
An indispensable resource for busy researchers

Your time is valuable-too valuable to spend hunting through the technical literature in search of the right
HPLC assay techniques for your projects. With HPLC Methods for Recently Approved Pharmaceuticals,
you'll quickly identify and replicate the ideal procedures for your project needs, without having to refer to
original source publications. More of your time can then be spent in the lab, not the library.

Covering the relevant world literature through 2003, this book picks up where Dr. Lunn's acclaimed HPLC
Methods for Pharmaceutical Analysis left off. It arms you with established HPLC assay techniques for
hundreds of newly approved drugs, as well as drugs for which assay methods were only recently
developed. Combining detailed descriptions of procedures with specially annotated references, this
practical handbook gives you:
* HPLC methods for 390 commonly prescribed pharmaceutical compounds
* Various procedures for each drug listed together-making it easy to mix and match for customized
approaches
* Methods for drugs in biological fluids and for bulk and formulated drugs
* Chemical structures, molecular weights and formulas, and CAS Registry Numbers
* Cross-references to The Merck Index
* Retention times of other drugs that can be assayed using the same methods

See all Editorial Reviews

Product Details

• Hardcover: 744 pages


• Publisher: Wiley-Interscience; 1 edition (April
18, 2005)
• Language: English

• ISBN-10: 0471669415

• ISBN-13: 978-0471669418

Pharmaceutical Extrusion Technology


(Drugs and the Pharmaceutical Sciences)
[Hardcover]
Isaac Ghebre-Selassie

Editorial Reviews

Product Description
The only book to bring together all technical information necessary to develop and market pharmaceutical
dosage forms that meet current quality and regulatory requirements. Provides in-depth descriptions and
analyses of the key parameters of extruders and extrusion processes—highlighting the applicability of melt
extrusion in pharmaceutical drug development and product manufacturing.

Product Details

• Hardcover: 420 pages

• Publisher: Informa Healthcare; 1 edition (May


1, 2003)
• Language: English

• ISBN-10: 0824740505

• ISBN-13: 978-0824740504

International Pharmaceutical Product


Registration [Hardcover]
A.C. Cartwright (Editor),
Product Description
This reference text for the pharmaceutical industry sets out the regulatory requirements of the authorities
of the major world market. The editors identify major key technical and scientific areas in any application
for marketing authorization.

Product Details

• Hardcover: 968 pages

• Publisher: Informa Healthcare (April


1994)
• Language: English

• ISBN-10: 013474974X

• ISBN-13: 978-0134749747

Pharmaceutical Microbiology [Paperback]


W. B. Hugo
Product Description
Formerly Univ. of Nottingham, UK. Text for pharmacy undergraduate students on microbiology as it relates
to pharmacy, such as mode of action of antibiotics or the manufacture and quality control of
pharmaceutical agents. Previous edition: c1992. Halftone illustrations. Referenced. Softcover.

See all Editorial Reviews

Product Details

• Paperback: 510 pages

• Publisher: Wiley-Blackwell; 6 edition (July


15, 1998)
• Language: English

• ISBN-10: 063204196X

• ISBN-13: 978-0632041961

Pharmaceutical Substances: Syntheses,


Patents, Applications
Axel Kleemann
Product Description
Pharmaceutical Substances is the newly revised and expanded edition of "Pharmazeutische Wirkstoffe" in
English, covering over 2,100 pharmaceutical compounds of interest to the chemical and pharmaceutical
industry. Available in print and CD-ROM, Pharmaceutical Substances is designed to be a complete
reference guide to every pharmaceutical compound of significance. It is essential as a first point of
reference not only for specialists in drug chemistry but also for anyone involved in the synthesis or use of
pharmaceuticals. All compounds are organized alphabetically according to INN standard, for added ease of
use the book features three additional indexes: Intermediates Enzymes, Microorganisms, Plants and
Animal Tissues Substance Classes The CD-ROM will allow field, full text and index searching. It includes a
browse function to allow you to peruse the data alphabetically by INN. It will be updated annually with 50
to 100 new compounds added each year.

See all Editorial Reviews

Product Details

• Hardcover: 2488 pages

• Publisher: Thieme Medical Publishers; 4th edition


(January 2001)
• Language: English

• ISBN-10: 3135584046

• ISBN-13: 978-3135584041

Transport Processes in Pharmaceutical


Systems (Drugs and the Pharmaceutical
Sciences: a Series of Textbooks and
Monographs)

L. Amidon

Product Description
Univ. of Michigan, Ann Arbor. Explains pharmaceutical transport phenomena, demonstrating applications
ranging from drug or nutrient uptake into vesicle or cell suspensions, to heat and mass transport in freeze-
drying and hygroscopicity. For researchers.

Product Details

• Hardcover: 727 pages

• Publisher: Informa Healthcare; 1st edition (January


15, 2000)
• Language: English

• ISBN-10: 0824766105

• ISBN-13: 978-0824766108

Industrial Pharmaceutical Biotechnology


[Hardcover]
Heinrich Klefenz
Product Description
This volume focuses on pharmaceutical biotechnology as a key area of life sciences. The complete range
of concepts, processes and technologies of biotechnology is applied in modern industrial pharmaceutical
research, development and production. The results of genome sequencing and studies of biological-genetic
function are combined with chemical, micro-electronic and microsystem technology to produce medical
devices and diagnostic biochips. A multitude of biologically active molecules is expanded by additional
novel structures created with newly arranged gene clusters and bio-catalytic chemical processes.
New organisational structures in the co-operation of institutes, companies and networks enable faster
knowledge and product development and immediate application of the results of research and process
development.
This book is the ideal source of information for scientists and engineers in research and development, for
decision-makers in biotech, pharma and chemical corporations, as well as for research institutes, but also
for founders of biotech companies and people working for venture capital corporations.

Product Details

• Hardcover: 393 pages

• Publisher: Wiley-VCH; 1 edition (May 7,


2002)
• Language: English

• ISBN-10: 3527299955

• ISBN-13: 978-3527299959

Affinity Capillary Electrophoresis in


Pharmaceutics and Biopharmaceutics
(Drugs and the Pharmaceutical Sciences)
[Hardcover]
Reinhard H.H. Neubert (Editor)
Product Description
Martin-Luther-University, Halle-Wittenberg, Germany. Text presents recent breakthroughs and techniques
in affinity capillary electrophoresis to measure and determine the physicochemical and thermodynamic
parameters of drug compounds. Offers strategies to explore and characterize interactions between drugs.

Product Details

• Hardcover: 384 pages

• Publisher: Informa Healthcare; 1 edition (January


14, 2003)
• Language: English

• ISBN-10: 0824709519

• ISBN-13: 978-0824709518

Pharmaceutical Stress Testing: Predicting


Drug Degradation (Drugs and the
Pharmaceutical Sciences) [Hardcover]
Steven W. Baertschi (Editor)
Product Description
The first book devoted to the topic, this reference discusses the predictive power and limitations of current
stress testing strategies and emphasizes the critical role of stress testing in the determination of the
stability characteristics of pharmaceuticals-offering an extensive compilation of drug degradation studies
from real-world examples in the literature.

Product Details

• Hardcover: 482 pages

• Publisher: Informa Healthcare; 1 edition (June


24, 2005)
• Language: English

• ISBN-10: 0824740211

• ISBN-13: 978-0824740214

Bioavailability and Bioequivalance in


Pharmaceutical Technology [Paperback]
Pal (Author)

Book: Bioavailability And Bioequivalence In Pharmaceutical Technology


Author: Pal
ISBN: 8123911580

Publishing Date: 2006-12-01


Publisher: Cbs Publishers And Distributors
Edition: 1st
Number of Pages: 159
Language: English
Handbook of Microbiological Quality
Control in Pharmaceuticals and Medical
Devices (Pharmaceutical Science Series)
[Hardcover]
Rosamund M. Baird (Editor)

Product Description
This book will be a practical guide to techniques used in microbial quality assurance in the pharmaceutical
industry. It aims to fill the gap in the literature between food and medical microbiology techniques books.

Product Details

• Hardcover: 280 pages

• Publisher: CRC Press; 1 edition (August


17, 2000)
• Language: English

• ISBN-10: 074840614X

• ISBN-13: 978-0748406142

Handbook of Pharmaceutical
Manufacturing Formulations, Second
Edition: (Six-Volume Set) [Hardcover]
Sarfaraz K. Niazi
Product Description
An authoritative and practical guide to the art and science of formulating drugs.
With thoroughly revised and expanded content, this Second Edition six-volume set compiles volumes from FDA New Drug
Applications, patent applications, and other sources of generic and proprietary formulations to cover the broad spectrum of issues
concerning drug manufacturing.
A must-have collection for pharmaceutical manufacturers, educational institutions, and regulatory authorities, this set is an excellent
platform for drug companies to benchmark their products and for generic companies to formulate drugs coming off patent.
As the largest reference on pharmaceutical formulations, this handbook also provides guidelines on how to file aNDAs in the shortest
possible time, helping pharmaceutical companies to cut costs in the areas of pharmaceutical research and development.
Divided conveniently into two parts—regulatory and manufacturing guidelines, and formulations—each volume in the set covers:
• cGMP compliance
• pre-approval inspections
• stability and bioequivalence testing
• packaging commodity development
• common difficulties in formulating drugs
• changes to aNDAs

Product Details

• Hardcover: 2094 pages

• Publisher: Informa Healthcare; 2 edition (September


21, 2009)
• Language: English

• ISBN-10: 1420081063

• ISBN-13: 978-1420081060

• Product Dimensions: 16.4 x 12.3 x 8.5 inches

Validation and Qualification in Analytical


Laboratories
B001JSB7IQ

Ludwig Huber

Ludwig Huber (Author)

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(Author)

Product Description
This Second Edition discusses ways to improve pharmaceutical product quality while achieving
compliance with global regulatory standards. With comprehensive step-by-step instructions, practical
recommendations, standard operating procedures (SOPs), checklists, templates, and graphics for easy
incorporation in a laboratory. This title serves as a complete source to the subject, and explains how to
develop and implement a validation strategy for routine, non-routine, and standard analytical methods,
covering the entire equipment, hardware, and software qualification process. It also provides guidance on
qualification of certified standards, in-house reference materials, and people qualification, as well as
internal and third party laboratory audits and inspections.

Product Details

• Hardcover: 288 pages

• Publisher: Informa Healthcare; 2 edition (July


23, 2007)
• Language: English

• ISBN-10: 084938267X

• ISBN-13: 978-0849382673

• Product Dimensions: 9 x 6.1 x 0.8 inches

Hvac Systems Duct Design [Paperback]


Smacna

Product Details
• Paperback
• Publisher: Sheet Metal & Air Conditioning; 3rd edition (June 1990)

• ISBN-10: 9991623825

• ISBN-13: 978-9991623825

• Product Dimensions: 11.2 x 8.8 x 1 inches


Pharmaceutical Suspensions: From
Formulation Development to
Manufacturing

Pharmaceutical Suspensions: From


Formulation Development to
Manufacturing Publisher: Springer |
Pages: 323 | 2009-10-16 | ISBN
1441910867 | 5 MB

The suspension dosage form has long been used for poorly soluble active ingredients for various
therapeutic indications. Development of stable dispersions over the shelf life of the drug product continues
to be a challenge on many fronts.

A good understanding of fundamentals of disperse systems is essential in the development of a suitable


pharmaceutical suspension. The development of suspension dosage form follows a very complicated path.
The selection of the proper excipients (surfactants, viscosity imparting agents etc.) is important. The
particle size distribution in the finished drug product dosage form is a critical parameter that significantly
impacts the bioavailability and pharmacokinetics of the product. Appropriate analytical methodologies and
instruments (chromatographs, viscometers, particle size analyzers, etc.) must be utilized to properly
characterize the suspension formulation. The development process continues with a successful scale-up of
the manufacturing process. Regulatory agencies around the world require clinical trials to establish the
safety and efficacy of the drug product. All of this development work should culminate into a regulatory
filing in accordance with regulatory guidelines. Pharmaceutical Suspensions, in its organization, follows the
development approach used widely in the pharmaceutical industry. The primary focus of this book is on
the classical disperse system – poorly soluble active pharmaceutical active dispersed in a suitable vehicle.
Pharmaceutical Preformulation and
Formulation: A Practical Guide from
Candidate Drug Selection to Commercial
Dosage Form [Hardcover]
Mark Gibson (Author)

Product Description
Written by a panel of experts, this book covers every stage of drug development, from candidate drug
selection to commercial formulation. It provides practical reference and pragmatic guide on what studies
need to be undertaken, for what reasons, and at what key stages of the drug development process. Going
beyond coverage of preformulation, the book discusses biopharmaceuticals, drug delivery, formulation,
and process development aspects of product development. The contributing authors share their
experience and expertise in significant chapters divided into three useful sections: Aiding Candidate Drug
Selection, Early Drug Development, and From Product Design to Commercial Dosage Form. Features

Product Details

• Hardcover: 596 pages

• Publisher: Informa Healthcare; 1 edition (August


1, 2001)
• Language: English

• ISBN-10: 1574911201

• ISBN-13: 978-1574911206

Pharmaceutical Formulation
Development of Peptides and Proteins
(The Taylor & Francis Series in
Pharmaceutical Sciences) [Hardcover]
Lars Hovgaard (Editor),
Product Description
This comprehensive volume brings the different aspects of peptide and protein formulation into focus,
beginning with the fundamentals of the production of peptides and proteins, ranging from synthesis to
protein purification.

Product Details

• Hardcover: 238 pages

• Publisher: CRC Press; 1 edition (December


16, 1999)
• Language: English

• ISBN-10: 0748407456

• ISBN-13: 978-0748407453

SAS Programming in the Pharmaceutical


Industry [Paperback]
B001K8CN9W

Jack Shostak

Jack Shostak (Author)

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Product Description
At last! A real-world reference guide for clinical trial SAS programming, packed with solutions that
programmers can apply to their day-to-day problems. Discover key techniques and tools available within
Base SAS (including the macro language and PROC SQL), SAS/GRAPH, and SAS/STAT that can be used to
resolve many common issues in working with clinical trial data. Organized to reflect the statistical
programmer's work flow, this user-friendly text begins with an introduction to the working environment,
then presents chapters on importing and massaging data into analysis data sets, producing clinical trial
output, and exporting data. Valuable plug-and-play programming examples are provided throughout.
Whether you're a novice seeking an introduction to SAS programming for the pharmaceutical industry or a
junior-level programmer exploring new approaches to problem solving, you'll find a wealth of practical
suggestions to help you sharpen your skills.

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Product Details

• Paperback: 360 pages

• Publisher: SAS Publishing; 1 edition


(September 2005)
• Language: English

• ISBN-10: 1590477936

• ISBN-13: 978-1590477939

Freeze-Drying/Lyophilization Of
Pharmaceutical & Biological Products,
Third Edition (Drugs and the
Pharmaceutical Sciences)
Louis Rey
Product Description
Freeze drying, or lyophilization, is a well established technology used in the preservation of numerous pharmaceutical and biological
products. This highly effective dehydration method involves the removal of water from frozen materials via the direct sublimation of
ice. In recent years, this process has met with many changes, as have the regulations that impact lyophilization practices. This new
edition of Freeze Drying/ Lyophilization of Pharmaceutical and Biological Products addresses these changes with updated and new
chapters on emerging developments in lyophilization technology, research, and industry procedures. Providing both a scientific and
industrial perspective, this comprehensive text is a valuable resource for all those who use freeze drying technology.

Product Details

• Hardcover: 640 pages

• Publisher: Informa Healthcare; 3 edition (June


15, 2010)
• Language: English

• ISBN-10: 1439825750

• ISBN-13: 978-1439825754

Pharmaceutical and Medical Applications


of Near-Infrared Spectroscopy (Practical
Spectroscopy) [Hardcover]
B001JS64KM

Emil W. Ciurczak

Emil W. Ciurczak (Author)

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(Author)

Product Description
This book discusses the theory, instrumentation, validation, and implementation of near-infrared
spectroscopy for pharmaceutical and medical applications. It showcases a diverse range of contemporary
methods for the production, screening, and analysis of new drug products and pharmaceuticals. Presents
current approaches in near-infrared spectroscopy (NIR) to monitor and control multiple phases of the drug
manufacturing process.

About the Author


Cadrai Technologies, Goldens Bridge, New York, USA United States Pharmacopeia, Rockville, Maryland,
USA --This text refers to an alternate Hardcover edition.

Product Details

• Hardcover: 208 pages

• Publisher: CRC Press; 1 edition (February


8, 2002)
• Language: English

• ISBN-10: 0824794532

• ISBN-13: 978-0824794538

Pharmaceutical Chemical Analysis:


Methods for Identification and Limit
Tests
B001JS7SYI

Ole Pedersen

Ole Pedersen (Author)

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(Author)

Product Description
Complete, referenced information in an easy-to-use format
Many of the monographs in the European Pharmacopiea, the industry standard test for certain groups of ingredients and excipients,
do not describe the tests in full, but reference general methods based on test-tube chemistry. When a test fails, you need to know what
went wrong, how it can be fixed, and how to convince QA\QC that the tested material is okay. This gives you little time to dig out the
relevant scientific literature, literature that is often so old it doesn’t show up in an electronic search.
Making this knowledge easily accessible and directly applicable to work in the lab, Pharmaceutical Chemical Analysis: Methods
for Limit Tests and Identifications explains the purpose of these older tests, the chemistry involved, and hazards to avoid. The book
covers the identification of ions and functional groups tests and limit tests respectively. It covers subjects relevant to all the
pharmacopoeial identification/limit test and then goes on to describe the individual tests in chapters organized and named as they
appear in the European Pharmacopoeia. Each chapter begins with a short discussion on the purpose and rationale of the tests,
followed by a review of the physical and chemical characters of the target ion or compound. The author describes the chemical
background and logic of the individual procedural steps of the test with formulas and reaction and provides tips on the strengths and
weaknesses of these techniques in terms of specificity, ruggedness, and potential procedural pitfalls.
Strict regulatory requirements and economic pressures make the pharmaceutical industry understandably reluctant to replace a test that
is simple, cheap, and performs well with expensive, unvalidated instrumental techniques. This resource bridges the gap by providing
an in-depth understanding of the principles behind the European Pharmacopoeia tests and how to use them, saving you valuable
production time.

Product Details

• Hardcover: 176 pages

• Publisher: CRC Press (January 13,


2006)
• Language: English

• ISBN-10: 0849319781

• ISBN-13: 978-0849319785

Pharmaceutical Drug Analysis [Hardcover]


Ashutosh Kar (Author)
Product Description
In this specific context the remarkable proliferation of windows-based computer software stretched
overwhelmingly towards instrument control, real time data handling abilities and the ultimate usage of
Laboratory Information Management Systems (LIMS) are surprisingly noteworthy. "Pharmaceutical Drug
Analysis" in its present form essentially comprise of six parts containing in all thirty-two well-elaborated
chapters predominantly dealing with the set of descriptive analytical methodologies developed to control
and assure the quality of the final marketed product; and, therefore, includes both qualitative and
quantitative methods of analysis to help in the identification as well as purity of the product. The main
purpose of this textbook is to discuss in an explicit and lucid manner several of the newer methods that
now find rather wider application in the domain of pharmaceutical analysis. The basic principle of each
technique is critically treated with emphasis on factors that directly affect its proper and judicious
application to various analytical problems. An in-depth knowledge of these principles, instrumentations,
modus operandi, experimental parameters, and sample preparation procedures in order to optimize the
performance procedure of typical assay of pharmaceutical secondary products i.e., dosage forms,
calculations etc., along with cognate assays from the Official Compendia have been included profusely.
Undergraduate and postgraduate students of pharmaceutical drug analysis, quality assurance chemists,
industrial trainees, bulk-drug professionals and those in related disciplines earnestly requiring a substantial
fundamental understanding and knowledge of the subject will certainly find this a much needed suitable
compilation for reading and reference. The broad coverage included in each of the selected analytical
techniques would render "Pharmaceutical Drug Analysis" to be an useful source of ideas, inspiration for
research, and developing newer practical solutions to problems in the ever expanding field of
pharmaceutical analysis.

Product Details

• Hardcover: 564 pages

• Publisher: New Age Publications (Academic) (December 1, 2006)

• ISBN-10: 8122416748

• ISBN-13: 978-8122416749

Name Reactions and Reagents in Organic


Synthesis [Hardcover]
B001HD04GE

Bradford P. Mundy

Bradford P. Mundy (Author)

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(Author), Michael G. Ellerd (Author), Frank G. Favaloro Jr. (Author)

Product Description
This Second Edition is the premier name resource in the field. It provides a handy resource for navigating
the web of named reactions and reagents. Reactions and reagents are listed alphabetically, followed by
relevant mechanisms, experimental data (including yields where available), and references to the primary
literature. The text also includes three indices based on reagents and reactions, starting materials, and
desired products. Organic chemistry professors, graduate students, and undergraduates, as well as
chemists working in industrial, government, and other laboratories, will all find this book to be an
invaluable reference.

See all Editorial Reviews

Product Details

• Hardcover: 904 pages

• Publisher: Wiley-Interscience; 2 edition (April


21, 2005)
• Language: English

• ISBN-10: 0471228540

• ISBN-13: 978-0471228547

Design and Analysis of Animal Studies in


Pharmaceutical Development (Chapman
& Hall/CRC Biostatistics Series) [Hardcover]
Shein-Chung Chow (Editor), Jen-pei Liu (Editor)
Product Details

• Hardcover: 424 pages

• Publisher: Chapman and Hall/CRC; 1 edition (January 15, 1998)

• Language: English

• ISBN-10: 0824701305

• ISBN-13: 978-0824701307

GMP/ISO Quality Audit Manual for


Healthcare Manufacturers and their
Suppliers, Sixth Edition, (Volume 1 - With
Checklis
B001KIFI1C

Leonard Steinborn

Leonard Steinborn (Author)

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(Author

Product Description
Volume 1 of this two-part package provides a complete set of checklists for internal and contract device
and drug manufacturers and developers, contract software developers, and suppliers of chemical, printed
material, electronic component, and general supplies. It also includes a simulated QSIT audit, and a new-
product market launch. All of these are referenced to the relevant relevant FDA regulations, EC and IPEC
guidelines, and ISO/BSI standards. The text also explains various audit types, do's and don'ts for auditors,
and guidance for audit preparation, performance, conclusion, report derivation, and follow up activities. A
CD-ROM packaged with the book contains all of the checklists in a customizable electronic format.

Product Details

• Ring-bound: 448 pages

• Publisher: Informa Healthcare; 6 edition (June


27, 2003)
• Language: English

• ISBN-10: 0849318467

• ISBN-13: 978-0849318467
GMP/ISO Quality Audit Manual for
Healthcare Manufacturers and Their
Suppliers, Sixth Edition (2 Volume Set):
GMP/ISO Quality Audit Manual for ...
and Guidelines): Regulations Volume 2
[Paperback]
B001KIFI1C

Leonard Steinborn

Leonard Steinborn (Author)

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(Author)

Product details

• Paperback: 452 pages

• Publisher: Informa Healthcare; 6th Revised edition edition (30 Dec 2004)

• Language English

• ISBN-10: 0849318475

• ISBN-13: 978-0849318474
Advanced Practical Medicinal Chemistry
[Paperback]
Ashutosh Kar (Author)

About the Author


Ashutosh Kar is a well-known Professor of Pharmaceutical Chemistry, presently, teaching at Shri RNS
College of Pharmacy, Gormi, Bhind (M.P.). He has to his credit twenty-seven years teaching experience at
undergraduate and graduate levels both in Indian Universities and abroad. He has published more than
twenty research papers based on pharmacological studies on natural and synthetic drugs in international
and national scientific journals. He has taught at School of Pharmacy, Addis Ababa University, Addis Ababa
(Ethiopia) (2002-2005); Guru Jhambheshwar University, Hisar (India) (1999-2002); Al-Arab Medical
University, Benghazi, (Libya) (1997-1998); College of Pharmacy (University of Delhi), Delhi (India) (1990-
1994); Faculty of Pharmaceutical Sciences, University of Nigeria, Nsukka (Nigeria) (1976-1987).

Product Details

• Paperback: 330 pages

• Publisher: New Age Publications (Academic) (January


30, 2009)
• ISBN-10: 8122415393

• ISBN-13: 978-8122415391

Chemical Analysis in the Laboratory: A


Basic Guide [Paperback]
B001K7NCCU

I. Mueller-Harvey
I. Mueller-Harvey (Author)

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(Author

Product Description
Provides basic training in the whole analytical process for students, demonstrating why analysis is
necessary and how to take samples, before they attempt to carry out any analysis in the laboratory.
Softcover.

Product Details

• Paperback: 112 pages


• Publisher: Royal Society of Chemistry; 1 edition
(September 10, 2002)
• Language: English

• ISBN-10: 0854046461

• ISBN-13: 978-0854046461

Food Energy - Methods of Analysis And


Conversion Factors [Paperback]
Bernan (Author
 Paperback

 Publisher: Bernan Assoc (March 2004)

 Language: English

 ISBN-10: 9251050147

 ISBN-13: 978-9251050149

Bioanalytical Separations, Volume 4


(Handbook of Analytical Separations)
Editorial Reviews

Review
"This is a well-written and informative volume. It brings the reader up to date on a wide range of issues
pertaining to separation methods in bioanalysis with special emphasis on sample preparation and LC-MS...
This book should be of high value for scientists working with drug analysis in biological fluids."
Alexander Nezlin, The Alchemist, February 2004.

Book Description
Volume 4 of the multi-volume series, Handbook of Analytical Separations

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Product Details

• Hardcover: 442 pages

• Publisher: Elsevier Science; 1 edition (September


17, 2003)
• Language: English

• ISBN-10: 0444506586

• ISBN-13: 978-0444506580

Advances in Chromatography
Edited by Phyllis R. Brown

• Price: $249.95

• Binding/Format: Hardback

• ISBN: 978-0-8247-9361-6
• Publish Date: January 20th 1995

• Imprint: CRC Press

• Pages: 448 pages


Description
"Volume 35 examines timely subjects such as performance requirements, detection modes, and ancillary techniques for optical
detectors in capillary electrophoresis; and more."

Handbook of Isolation and


Characterization of Impurities in
Pharmaceuticals, Volume 5 (Separation
Science and Technology) [Hardcover]
Satinder Ahuja (Author), Karen Mills Alsante (Author)

Product Description
The United States Food and Drug Administration (FDA) and other regulatory bodies around the world
require that impurities in drug substance and drug product levels recommended by the International
Conference on Harmonisation (ICH) be isolated and characterized.

Identifying process-related impurities and degradation products also helps us to understand the production
of impurities and assists in defining degradation mechanisms. When this process is performed at an early
stage, there is ample time to address various aspects of drug development to prevent or control the
production of impurities and degradation products well before the regulatory filing and thus assure
production of a high-quality drug product.

This book, therefore, has been designed to meet the need for a reference text on the complex process of
isolation and characterization of process-related (synthesis and formulation) impurities and degradation
products to meet critical requlatory requirements.

It's objective is to provide guidance on isolating and characterizing impurities of pharmaceuticals such as
drug candidates, drug substances, and drug products. The book outlines impurity identification processes
and will be a key resource document for impurity analysis, isolation/synthesis, and characterization.

- Provides valuable information on isolation and characterization of impurities.


- Gives a regulatory perspective on the subject.
- Describes various considerations involved in meeting regulatory requirements.
- Discusses various sources of impurities and degredation products.

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Product Details

• Hardcover: 430 pages

• Publisher: Academic Press; 1 edition (August


1, 2003)
• Language: English

• ISBN-10: 012044982X

• ISBN-13: 978-0120449828

Drug-like Properties: Concepts, Structure


Design and Methods: from ADME to
Toxicity Optimization [Hardcover]
B001ILIAHU

Edward Kerns

Edward Kerns (Author)

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B001ILFMAI

(Author), Li Di

Li Di (Author)

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(Author)
Product Description
Of the thousands of novel compounds that a drug discovery project team invents and that bind to the
therapeutic target, typically only a fraction of these have sufficient ADME/Tox properties to become a drug
product. Understanding ADME/Tox is critical for all drug researchers, owing to its increasing importance in
advancing high quality candidates to clinical studies and the processes of drug discovery. If the properties
are weak, the candidate will have a high risk of failure or be less desirable as a drug product. This book is a
tool and resource for scientists engaged in, or preparing for, the selection and optimization process.

The authors describe how properties affect in vivo pharmacological activity and impact in vitro assays.
Individual drug-like properties are discussed from a practical point of view, such as solubility, permeability
and metabolic stability, with regard to fundamental understanding, applications of property data in drug
discovery and examples of structural modifications that have achieved improved property performance.
The authors also review various methods for the screening (high throughput), diagnosis (medium
throughput) and in-depth (low throughput) analysis of drug properties.

* Serves as an essential working handbook aimed at scientists and students in medicinal chemistry
* Provides practical, step-by-step guidance on property fundamentals, effects, structure-property
relationships, and structure modification strategies
* Discusses improvements in pharmacokinetics from a practical chemist's standpoint

Product Details

• Hardcover: 552 pages

• Publisher: Academic Press; 1 edition (February


19, 2008)
• Language: English

• ISBN-10: 0123695201

• ISBN-13: 978-0123695208
Development of Biopharmaceutical
Parenteral Dosage Forms (Drugs and the
Pharmaceutical Sciences) [Hardcover]
Bontempo (Author)

Product Description
This up-to-the-minute reference delineates;in a systematic fashion;the appropriate, sequential steps for
the formulation of safe, effective, stable, and marketable liquid parenteral biopharmaceutical
products;covering fundamentals and essential pathways for each phase as well as its purpose, function,
and relation to other stages in the product development process. Written by experts currently involved in
state-of-the-art advances in the pharmaceutical drug industry, Development of Biopharmaceutical
Parenteral Dosage Forms details biopharmaceuticals that are licensed or undergoing clinical development,
including genetically engineered cell and engineered vectors in the fermentation process describes
purification and characterization techniques for rDNA therapeutics, discussing several types of unit
operations for isolation, purification, and characterization considers preformulation and formulation
requirements, such as physicochemical properties, drug delivery, stability studies programs,
deactivation/denaturation routes, selection of compatible excipients, and regulatory compliance elucidates
basics of analytical techniques, methods development, separation methods using chromatographic and
electrophoretic techniques, and bioactivity methods covering bioassays and immunoassays for quantifying
the stability of biological activity shows how to select the appropriate filter for maximizing compatibility
and minimizing adsorption and inactivation, examining topics from basic filtration theories to future trends
reviews the selection process for compatible elastomeric closures, analyzing physical, chemical,
toxicological properties, protein adsorption on elastomeric surfaces, strategies to reduce/eliminate
adsorption, and specialized containers for biotechnological applications and more! Furnished with helpful
references, tables, and drawings, this practical guide is indispensable for pharmaceutical, medicinal, and
protein chemists; molecular biologists; process engineers; purification scientists; biopharmaceutical and
pharmaceutical formulators and product developers; quality control, quality assurance, and regulatory
compliance personnel; and upper-level undergraduate and graduate students in these disciplines.
Product Details

• Hardcover: 264 pages

• Publisher: Informa Healthcare; 1 edition (July


25, 1997)
• Language: English

• ISBN-10: 082479981X

• ISBN-13: 978-0824799816

Analytical Measurement Terminology:


Handbook of Terms Used in Quality
Assurance of Analytical Measurement
(Valid Analytical Measurement) [Paperback]
E. Prichard (Author)

Product Description
This unique handbook explains the most commonly used terminology and places each term in context.
Concepts are described in a way that make them meaningful to practitioners and in line with ¿official
definitions¿ developed by international organizations.

Product Details

• Paperback: 86 pages

• Publisher: Royal Society of Chemistry; 1 edition


(November 9, 2001)
• Language: English

• ISBN-10: 0854044434

• ISBN-13: 978-0854044436