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
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Guideline on the investigation of bioequivalence (Rev.1) (PDF/232.75 KB)
Adopted
First published: 29/01/2010
Last updated: 10/03/2010
Legal effective date: 01/08/2010
CPMP/EWP/QWP/1401/98 Rev. 1 -
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Overview of comments received on draft guideline on the investigation of bioequivalence CPMP/EWP/QWP/1401/98 Rev. 1 (PDF/1.5 MB)
First published: 10/02/2010
Last updated: 10/02/2010
EMA/CHMP/EWP/26817/2010 -
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Draft guideline on the investigation of bioequivalence (PDF/435.84 KB)
Draft: consultation closed
First published: 24/07/2008
Last updated: 24/07/2008
CPMP/EWP/QWP/1401/98 Rev. 1 -
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Concept paper on BCS-based biowaiver (PDF/43.41 KB)
First published: 24/05/2007
Last updated: 24/05/2007
EMEA/CHMP/EWP/213035/2007 -
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Recommendation on the need for revision of (CHMP) (note for guidance on the investigation of bioavailability and bioequivalence) (PDF/37.52 KB)
First published: 24/05/2007
Last updated: 24/05/2007
EMEA/CHMP/EWP/200943/2007