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Proposal for defining the relevance of drug accumulation derived from single dose study data for modified release dosage forms

Recently, the European Medicines Agency (EMA) published the new draft guideline on the pharmacokinetic and clinical evaluation of modified release (MR) formulations. The draft guideline contains the new requirement of performing multiple dose (MD) bioequivalence studies, in the case when the MR form...

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Библиографические подробности
Опубликовано в: :Biopharm Drug Dispos
Главные авторы: Scheerans, Christian, Heinig, Roland, Mueck, Wolfgang
Формат: Artigo
Язык:Inglês
Опубликовано: Blackwell Publishing Ltd 2015
Предметы:
Online-ссылка:https://ncbi.nlm.nih.gov/pmc/articles/PMC4405076/
https://ncbi.nlm.nih.gov/pubmed/25327367
https://ncbi.nlm.nih.govhttp://dx.doi.org/10.1002/bdd.1923
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