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Different approaches to bioequivalence trials for EMA evaluation

05:35 EDT 23 Sep 2016 | Generics and Biosimilars Initiative

Selection of robust bioequivalence study designs is a difficult task for manufacturers of generics. Author Nathaniel Refalo from the Malta Medicines Authority and colleagues therefore investigated whether different approaches in various products assessed by the European Medicines Agency (EMA) during the approval phase resulted in a reduction in the resources required to show bioequivalence [1].

Original Article: Different approaches to bioequivalence trials for EMA evaluation

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