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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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Detalhes bibliográficos
Publicado no:Clin Pharmacol Ther
Main Authors: Sullivan, Jane O', Blake, Kevin, Berntgen, Michael, Salmonson, Tomas, Welink, Jan
Formato: Artigo
Idioma:Inglês
Publicado em: John Wiley and Sons Inc. 2018
Assuntos:
Acesso em linha:https://ncbi.nlm.nih.gov/pmc/articles/PMC6175295/
https://ncbi.nlm.nih.gov/pubmed/29319156
https://ncbi.nlm.nih.govhttp://dx.doi.org/10.1002/cpt.957
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