Investigation of bioequivalence - Scientific guideline

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

Current effective version

Guideline on the investigation of bioequivalence (Rev.1)

AdoptedLegal effective date: 01/08/2010Reference Number: CPMP/EWP/QWP/1401/98 Rev. 1

Document history - Revision 1 (current version)

Guideline on the investigation of bioequivalence (Rev.1)

AdoptedLegal effective date: 01/08/2010Reference Number: CPMP/EWP/QWP/1401/98 Rev. 1

Overview of comments received on draft guideline on the investigation of bioequivalence CPMP/EWP/QWP/1401/98 Rev. 1

Reference Number: EMA/CHMP/EWP/26817/2010

Draft guideline on the investigation of bioequivalence

Draft: consultation closedReference Number: CPMP/EWP/QWP/1401/98 Rev. 1

Concept paper on BCS-based biowaiver

Reference Number: EMEA/CHMP/EWP/213035/2007

Recommendation on the need for revision of (CHMP) (note for guidance on the investigation of bioavailability and bioequivalence)

Reference Number: EMEA/CHMP/EWP/200943/2007

Document history - First version

Note for guidance on the investigation of bioavailability and bioequivalence

AdoptedLegal effective date: 01/01/2002Reference Number: CPMP/EWP/QWP/1401/98