European Medicines Agency. Qualification of Novel Methodologies for Drug Development: Guidance to Applicants (EMA/CHMP/SAWP/72894/2008). 2014.

Published by European Medicines Agency (EMA)

EMA Guideline Pharmaceuticals Drug Development

This guidance is for qualification process addresses innovative drug development methods and tools. It will focus on the use of novel methodologies developed by consortia, networks, public/private partnerships, learned societies and pharmaceutical industry for a specific intended use in pharmaceuticals R&D.

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European Medicines Agency. Qualification of Novel Methodologies for Drug Development: Guidance to Applicants (EMA/CHMP/SAWP/72894/2008). 2014.

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