Investigation of bioequivalence

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Current effective version

Revision 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

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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