Investigation of bioequivalence

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Current effective version

Revision 1 - Adopted guideline

Reference numberCPMP/EWP/QWP/1401/98 Rev. 1
Effective from01/08/2010
KeywordsBioequivalence, pharmacokinetics, biowaiver, BCS-based biowaiver, in vitro dissolution, generics
DescriptionThis 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.

Document history

Revision 1 

Current version

Adopted guideline

Overview of comments

Draft guideline

Concept paper on BCS-based biowaivers

Concept paper on the need for revision

In operation: 01/08/2010–present

Published: 10/02/2010

Published: 24/07/2008

Published: 24/05/2007

Published: 24/05/2007

First versionAdopted guidelineIn operation: 01/01/2002–31/07/2010

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