Concept paper on the development of product-specific guidance on demonstration of bioequivalence

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Download document Concept paper on the development of product-specific guidance on demonstration of bioequivalence
Reference number EMA/CHMP/423137/2013
Status draft: consultation closed
First published 2013-08-01
Last updated 2013-08-01

Summary

This document describes for specific products the regulatory view on specific aspects related to the demonstration of bioequivalence based on previous assessments of generic medicines.