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 open
First published 01/08/2013
Last updated 01/08/2013
Consultation start date 01/08/2013
Consultation end date 30/09/2013
Email address for submissions pkwpsecretariat@ema.europa.eu

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.