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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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Библиографические подробности
Опубликовано в: :Clin Pharmacol Ther
Главные авторы: Sullivan, Jane O', Blake, Kevin, Berntgen, Michael, Salmonson, Tomas, Welink, Jan
Формат: Artigo
Язык:Inglês
Опубликовано: John Wiley and Sons Inc. 2018
Предметы:
Online-ссылка: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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