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

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...

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Detalles Bibliográficos
Autores principales:	Lenić, Ines, Blake, Kevin, Garcia‐Arieta, Alfredo, Potthast, Henrike, Welink, Jan
Formato:	Online Artículo Texto
Lenguaje:	English
Publicado:	John Wiley and Sons Inc. 2019
Materias:	Research
Acceso en línea:	https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6742938/ https://www.ncbi.nlm.nih.gov/pubmed/31046182 http://dx.doi.org/10.1111/cts.12642

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