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Overview of the European Medicines Agency's Development of Product‐Specific Bioequivalence Guidelines

The European Medicines Agency's (EMA) product‐specific bioequivalence guidelines outline harmonized regulatory requirements for studies to demonstrate bioequivalence for products that may have particular needs due to their pharmacokinetics, in addition to those outlined in general guidance. As...

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Detalles Bibliográficos
Autores principales:	Sullivan, Jane O', Blake, Kevin, Berntgen, Michael, Salmonson, Tomas, Welink, Jan
Formato:	Online Artículo Texto
Lenguaje:	English
Publicado:	John Wiley and Sons Inc. 2018
Materias:	Research
Acceso en línea:	https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6175295/ https://www.ncbi.nlm.nih.gov/pubmed/29319156 http://dx.doi.org/10.1002/cpt.957

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