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

Document history - First version (current)


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