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

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

Current effective version

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

AdoptedLegal effective date: 01/06/2012Reference Number: EMA/CHMP/600958/2010Summary:

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.

Document history - First version (current)

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

AdoptedLegal effective date: 01/06/2012Reference Number: EMA/CHMP/600958/2010Summary:

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.

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...

Reference Number: EMA/CHMP/643484/2011

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

Consultation dates: 17/02/2011 to 31/05/2011Draft: consultation closedReference Number: EMA/CHMP/600958/2010

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

Consultation dates: 22/04/2010 to 31/07/2010Draft: consultation closedReference Number: EMA/CHMP/EWP/82259/2010