Investigation of bioequivalence

This document specifies the requirements for the design, conduct, and evaluation of bioequivalence studies for immediate release dosage forms with systemic action. Read together with Appendix IV.

Keywords: Bioequivalence, pharmacokinetics, biowaiver, BCS-based biowaiver, in vitro dissolution, generics

Document history - Revision 1 (current version)

How useful was this page?

Add your rating
1 rating
2 ratings
1 rating