EMA Releases API Bioequivalence Studies Guidance

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.

The guidance documents, which can be found on EMA’s website, are available for comment until Nov. 1, 2015.