(Review) First-in-Human Studies - PMDA-ATC Learning Videos
Автор: Pmda Channel
Загружено: 2023-05-07
Просмотров: 1767
Описание: PMDA reviews Investigational New Drug (IND) data submitted by the sponsor to evaluate the safety of administering the pharmaceutical agent in first-in-human (FIH) clinical trials. This video gives an introduction to the guidance for FIH studies in Japan, and the methods used to determine the FIH initial dose.
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