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Bioavailability and
Drug product performance
bioequivalence can be
studies are used in the
considered as measures of the
development of new and
drug product performance in
generic drug products
vivo
Bioequivalence Studies in New Drug
Development (NDA)
• Bioequivalence studies are used to compare
1. Early and late clinical trial formulations
2. Formulations used in clinical trials and stability studies, if different;
3. Clinical trial formulations and to-be-marketed drug products, if
different;
4. Product strength equivalence, as appropriate.
• Bioequivalence study designs are used to support new formulations
of previously approved products, such as a new fixed-dose
combination version of two products approved for coadministration,
or modified-release versions of immediate-release products.