Formatting of Bioequivalence Summary Tables

1. 2. #. *. ". 3. Please provide these tables as pdf files and in MSWord. Place the MSWord format of all the tables in Module 2.7 and the pdf files in the appropriate eCTD/CTD locations. Mar ins for the paper should be 1! for the top and bottom and 1.2"! for the left and ri ht sides. $ll te%t should be Times &e' (oman 1). Please use the Default Table St+le 'hen creatin the tables 'hen the+ are created in Microsoft, Word. -Select Menu Table.Table $uto /ormat.Table &ormal0 Table 11 Table *1 Table 71 Table 21 and Tables 1).13 should be in P4(T($5T orientation. Table 21 Table #1 Table "1 Table 31 Table 6 should be in 7$&DSC$P8 orientation.

Table 1 Submission Summary

Drug Product Name Strength(s) !!licant Name ddress Point of "ontact Name ddress Tele!hone Number Fa# Number 4r1 please provide an electronic cop+ of /orm #"39.

This information is needed for a complete ;ioe<uivalence revie' and1 althou h re<uired for the archival cop+ submitted to the $ enc+1 it is fre<uentl+ not readil+ available in the ;ioe<uivalence Submission. The Division of ;ioe<uivalence prefers that this information be submitted as a electronic /orm #"39. 5f this is not possible1 then please complete Table 1.

Table $ Summary of Bioavailability Studies

Study %ef& No& Study 'b(ective Treatments (Dose) Dosage Form) %oute) *Product +D, Test product stren th Tab./Cap./Susp p.o. ?;atch =@ (ef. product stren th Tab./Cap./Susp p.o. ?;atch =@ Test product stren th Tab./Cap./Susp p.o. ?;atch =@ (ef. product stren th Tab./Cap./Susp p.o. ?;atch =@ Sub(ects (No& (-.F) Ty!e ge/ mean (%ange) -ean Parameters (0.1SD) "ma# (units.m2) Tma# (hr) 3"41t (units) 3"5 (units) T6 (hr) 7el (hr11) Study %e!ort 2ocation

Study Design

Stud+ =

(andomi>ed /astin stud+ sin le.dose title crossover

= completin -=M/=/0 9ealth+ subAects or patients mean a e -ran e0

M -BCC0 M -BCC0

Median M M -(an e0 M -BCC0 M -BCC0 -BCC0 -BCC0 Col.= p.= M M Median M -BCC0 M -BCC0 -BCC0 -BCC0 -(an e0

Stud+ =

/ed stud+ title

(andomi>ed sin le.dose crossover

= completin -=M/=/0 9ealth+ subAects or patients mean a e -ran e0

M -BCC0 M -BCC0

M M Median M -BCC0 M -BCC0 -BCC0 -BCC0 -(an e0 M M Median M -BCC0 M -BCC0 -BCC0. -BCC0 -(an e0

Col.= p.=

Table 8 Statistical Summary of the "om!arative Bioavailability Data

Drug Dose (9 # mg) 2east Squares :eometric -eans) %atio of -eans) and ;4< "onfidence +ntervals Fasted Bioequivalence Study (Study No&) Test %eference %atio

Parameter 3"41t 3"5 "ma# Parameter 3"41t 3"5 "ma#

;4< "&+&

Test

Fed Bioequivalence Study (Study No&) %eference

%atio

;4< "&+&

Table = Bioanalytical -ethod >alidation

+nformation %equested Bioanalytical method validation re!ort location nalyte +nternal standard (+S) -ethod descri!tion 2imit of quantitation verage recovery of drug (<) verage recovery of +S (<) Standard curve concentrations (units.m2) ?" concentrations (units.m2) ?" +ntraday !recision range (<) ?" +ntraday accuracy range (<) ?" +nterday !recision range (<) ?" +nterday accuracy range (<) Bench1to! stability (hrs) Stoc@ stability (days) Processed stability (hrs) FreeAe1thaB stability (cycles) 2ong1term storage stability (days) Dilution integrity Selectivity Please include table for each anal+te. Please submit all Method Calidation S4Ps. Data Provide the volume-s0 and pa e-s0 Provide the name-s0 of the anal+te-s0 5dentif+ the internal standard used ;rief description of e%traction methodD anal+tical method 74E1 units B B Standard curve ran e and appropriate concentration units 7ist all the concentrations used (an e or per EC (an e or per EC (an e or per EC (an e or per EC hours F room temperature da+s F *GC hours F room temperatureD hours F *GC = c+cles 17 da+s F .2)GC -or other0 Concentration diluted H.fold &o interferin peaIs noted in blanI plasma samples

Table C Summary of +n >itro Dissolution Studies

Dissolution "onditions !!aratus/ S!eed of %otation/ -edium/ >olume/ Tem!erature/

FirmDs Pro!osed S!ecifications Dissolution Testing Site (Name) ddress) Study %ef No& Stud+ (eport =J Stud+ (eport =J Testing Date Product +D E Batch No& (Test 1 -anufacture Date) (%eference F G#!iration Date) Test Product Dosage Strength H Form m Tablet Capsule m Tablet Capsule No& of Dosage 3nits 12 "ollection Times (minutes or hours) Study %e!ort 2ocation

(eference Product

12

Mean (an e BCC Mean (an e BCC

Provide dissolution data for all stren ths -test and reference0.

Table I Formulation Data

+ngredient "ores mount (mg) . Tablet Strength 1 Strength $ mount (<) . Tablet Strength 1 Strength $

"oating

Total Please include the formulation of all stren ths.

144&44

144&4

Table J Demogra!hic Profile of Sub(ects "om!leting the Bioequivalence Study

Study No& Treatment :rou!s Test Product %eference Product NK NK ") K 1" 21 . 3* &-B0 &-B0 &-B0 &-B0 &-B0 &-B0 &-B0 &-B0 &-B0 &-B0 &-B0 &-B0 &-B0 &-B0 &-B0 &-B0 &-B0 &-B0 &-B0 &-B0 &-B0 &-B0 &-B0 &-B0

$ e -+ears0 $ e Lroups

Se% (ace

;M5 4ther /actors

Mean K SD (an e M 12 12 N *) *) N 3* 3" N 7" O 7" Male /emale $sian ;lacI Caucasian 9ispanic 4ther Mean K SD (an e

Please provide a separate table for each ;ioe<uivalence Stud+

Table L +ncidence of dverse Gvents in +ndividual Studies

Body System . dverse Gvent ;od+ as a 'hole Di>>iness 8tc. Cardiovascular 9+potension 8tc. Lastrointestinal Constipation 8tc. 4ther or an s+s. %e!orted +ncidence by Treatment :rou!s Fasted.Fed Bioequivalence Study Study No& Test %eference & -B0 & -B0 & -B0 & -B0

Total

& -B0

& -B0

Provide separate table for each ;ioe<uivalence Stud+

Table ; %eanalysis of Study Sam!les

Study No& dditional information in >olume(s)) Page(s) Number of sam!les reanalyAed Number of recalculated values used after reanalysis ctual number < of total assays ctual number < of total assays T % T % T % T %

%eason Bhy assay Bas re!eated

PharmacoIinetic1 (eason $ -e. . belo' 74E0 (eason ; (eason C 8tc. Total 1 . 5f no repeats 'ere performed for pharmacoIinetic reasons1 insert P).).! Please provide a separate table for each anal+te measured for each in.vivo stud+.

Table 14 Study +nformation

Study Number Study Title "linical Site (Name) ddress) Phone 9) Princi!al +nvestigator Dosing Dates nalytical Site (Name) ddress) Phone 9) nalysis Dates nalytical Director Storage Period of Biostudy Sam!les (no& of days from the first day of sam!le collection to the last day of sam!le analysis) Please provide separate table for each ;ioe<uivalence Stud+

Table 11 Product +nformation

Product Treatment +D Product Name -anufacturer Batch.2ot No& -anufacture Date G#!iration Date Strength Dosage Form Bio1batch SiAe Production Batch SiAe Potency "ontent 3niformity (mean) <">) Dose dministered %oute of dministration Test %eference

&/$ &/$

&/$ &/$ &/$

Table 1$ Dro!out +nformation

Sub(ect No Study No& %eason for dro!out.re!lacementM Period %e!lacedN %e!laced Bith

Please provide separate table for each ;ioe<uivalence Stud+ Q Please provide time1 treatment -test or reference01 and cause of dropout1 if reason of dropout is other than Ppersonal reasons!.

Table 18 Protocol Deviations

Study No& Ty!e Sub(ect 9s (Test) Sub(ect 9s (%ef&)

Please provide a separate table for each ;ioe<uivalence Stud+

Table 1= Summary of Standard "urve and ?" Data for Bioequivalence Sam!le nalyses
Bioequivalence Study No& nalyte Name Standard "urve Sam!les

Parameter Concentration -n 1 mc /m70 5nter da+ Precision -BCC0 5nter da+ $ccurac+ -B$ctual0 7inearit+ 7inearit+ (an e -n 1 mc /m70 Sensitivit+/74E -n 1 mc /m70

-(an e of (2 values0

Parameter Concentration -n 1 mc /m70 5nter da+ Precision -BCC0 5nter da+ $ccurac+ -B$ctual0

Bioequivalence Study No& nalyte Name ?uality "ontrol Sam!les

5f applicable1 please provide separate tables for the parent dru and metabolite-s0

Table 1C S'PDs Dealing Bith Bioanalytical %e!eats of Study Sam!lesM

S'P No& Gffective Date of S'P S'P Title

Q Please include the S4P for ;ioanal+tical (epeats in +our submission.

Table 1I "om!osition of -eal 3sed in Fed Bioequivalence Study

"om!osition /at Carboh+drate Protein Total "om!osition of -eal 3sed in Fed Bioequivalence Study Percent of total 7cal 7cal

5f the standard meal referenced in the CD8( Luidance for 5ndustr+ /ood.8ffect ;ioavailabilit+ and /ed ;ioe<uivalence Studies is used1 then it is not necessar+ to complete the table. 5n that case1 please add a statement in the fed bioe<uivalence stud+ report indicated that the P/D$ standard meal! 'as used. 5f an alternative meal is used1 then please complete the above summar+ table.