EMA to streamline bioequivalence testing for specific generic substances

This article was originally published in SRA

06 Aug 2013
News

Ian Schofield @ScripIanS ian.schofield@informa.com

Executive Summary

Companies planning generic drug submissions in the EU are to have new guidance on how to demonstrate the bioequivalence of specific active substances, in an effort to make bioequivalence assessment more transparent and predictable.

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EMA to streamline bioequivalence testing for specific generic substances

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