Investigation of bioequivalence

Current effective version

PDF iconRevision 1 - Adopted guideline

Reference numberCPMP/EWP/QWP/1401/98 Rev. 1
Published29/01/2010
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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