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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Bibliografiske detaljer
Udgivet i:Clin Pharmacol Ther
Main Authors: Sullivan, Jane O', Blake, Kevin, Berntgen, Michael, Salmonson, Tomas, Welink, Jan
Format: Artigo
Sprog:Inglês
Udgivet: John Wiley and Sons Inc. 2018
Fag:
Research
Online adgang: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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