Appendix IV of the guideline on the investigation on bioequivalence: presentation of biopharmaceutical and bioanalytical data in module 2.7.1

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Current effective version

Adopted guideline

Reference numberEMA/CHMP/600958/2010
Effective from01/06/2012
KeywordsGeneric applications, bioequivalence data, biopharmaceutics classification system (BCS), biowaiver documentation, standardised presentation
DescriptionThis 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.

Document history

First version

Current version

Adopted guideline

Overview of comments

Draft guideline

Concept paper

In operation: 01/06/2012–present

Published: 18/11/2011

Published: 14/03/2011

Published: 30/04/2010

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