EMA Releases API Bioequivalence Studies Guidance
The agency has released guidance on bioequivalence studies for asenapine, prasugrel, sitagliptin, and zonisamide.
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.
Source: EMA
INTERPHEX 2025: Critical Role of Walk-In Chambers in Bio/Pharma Development and Manufacturing
April 3rd 2025Christopher Murphy, director of Global Business Development and Service Customer Support at Environmental Specialties, sat down with the PharmTech Group at INTERPHEX 2025 to discuss the design and critical role of walk-in chambers in the bio/pharmaceutical industry.
