BEBAC   Ing. Helmut Schütz

EMA

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

Appendix IV (EMA/CHMP/600958/2010) was adopted by EMA’s CHMP on 17 November 2011 and is effective with 01 June 2012.

From the Introduction:

The objective of CTD Module 2.7.1 is to summarize all relevant information in the MAA dossier with regard to biopharmaceutic studies and associated analytical methods.

This Appendix 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. Furthermore, it is anticipated that a standardized presentation will facilitate the evaluation process. The use of these template tables is therefore recommended to applicants when preparing Module 2.7.1. This Appendix is intended for generic applications according to Directive 2001/83/EC, Article 10(1). Furthermore, if appropriate then it is also recommended to use these template tables in other applications such as variations, fixed combinations, extensions and hybrid applications.


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