New product-specific bioequivalence guidance
Journal Title: Generics and Biosimilars Initiative Journal - Year 2014, Vol 3, Issue 1
Abstract
For harmonization of the authorization requirements for specific generic applications within the EU, consistent criteria were drafted for 16 active substances, which are out now for public consultation.
Authors and Affiliations
Christoph Baumgärtel
Keywords
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- EP ID EP354200
- DOI 10.5639/gabij.2014.0301.009
- Views 115
- Downloads 0
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