Overview of the European Medicines Agency's Experience With Biowaivers in Centralized Applications

• Main Authors: Ines Lenić (Author), Kevin Blake (Author), Alfredo Garcia‐Arieta (Author), Henrike Potthast (Author), Jan Welink (Author)
• Format: Bog
• Udgivet: Wiley, 2019-09-01T00:00:00Z.
• Fag: article
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The waiver of the in vivo demonstration of bioequivalence (biowaiver) is an established tool in drug development and regulatory assessment. This study reviews the use of different biowaiver approaches in centralized applications for marketing authorization to the European Medicines Agency for generi...