Appendix IV of the guideline on the investigation on bioequivalence: presentation of biopharmaceutical and bioanalytical data in module 2.7.1 - Scientific guideline
Table of contents
This document is an appendix to the guideline on the investigation of bioequivalence. It contains a set of template tables to assist applicants in the preparation of Module 2.7.1 providing guidance with regard to data to be presented.
Keywords: Generic applications, bioequivalence data, biopharmaceutics classification system (BCS), biowaiver documentation, standardised presentation
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Appendix IV of the guideline on the investigation on bioequivalence (CPMP/EWP/QWP/1401/98 Rev.1): Presentation of biopharmaceutical and bioanalytical data in module 2.7.1 (PDF/138.26 KB)
Adopted
First published: 18/11/2011
Last updated: 08/12/2011
Legal effective date: 01/06/2012
EMA/CHMP/600958/2010 -
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Overview of comments received on 'appendix IV of the guideline on the investigation on bioequivalence (CPMP/EWP/QWP/1401/98 Rev.1): Presentation of biopharmaceutical and bioanalytical data in module 2.7.1 (EMA/CHMP/60095... (PDF/231.61 KB)
First published: 18/11/2011
Last updated: 18/11/2011
EMA/CHMP/643484/2011 -
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Draft appendix IV of the guideline on the investigation on bioequivalence (CPMP/EWP/QWP/1401/98 Rev.1): Presentation of biopharmaceutical and bioanalytical data in module 2.7.1 (PDF/154.85 KB)
Draft: consultation closed
First published: 14/03/2011
Last updated: 14/03/2011
Consultation dates: 17/02/2011 to 31/05/2011
EMA/CHMP/600958/2010 -
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Concept paper on the need to develop an appendix to the guideline on bioequivalence regarding the presentation of biopharmaceutical and bioanalytical data in application dossiers (PDF/103.56 KB)
Draft: consultation closed
First published: 30/04/2010
Last updated: 30/04/2010
Consultation dates: 22/04/2010 to 31/07/2010
EMA/CHMP/EWP/82259/2010
