Nate Edwards of Arya Consulting moderates a discussion with Elisabeth Gardiner of Tevard Biosciences and Donny Xu of the RTW Institute about the regulatory and manufacturing hurdles facing rare disease drug developers.
|Articles|July 16, 2015
EMA Releases API Bioequivalence Studies Guidance
Author(s)BioPharm International Editors
The agency has released guidance on bioequivalence studies for asenapine, prasugrel, sitagliptin, and zonisamide.
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The European Medicines Agency (EMA) opened up for consultation product-specific guidance documents on bioequivalence studies for the active substances asenapine, prasugrel, sitagliptin, and zonisamide. The release of the guidance documents follows finalization of bioequivalence guidance on 16 active substances in 2014 and 2015.
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