Investigation of bioequivalence

Current effective version

PDF iconRevision 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

PDF iconAdopted guideline

PDF iconOverview of comments

PDF iconDraft guideline

PDF iconConcept paper on BCS-based biowaivers

PDF iconConcept 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 version PDF iconAdopted guideline In operation: 01/01/2002–31/07/2010

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