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Application of Model-Informed Drug Development (MIDD) for Dose Selection in Regulatory Submissions for Drug Approval in Japan

Tomohiro Sasaki, Takayuki Katsube,Seiichi Hayato, Shingo Yamaguchi, Jun Tanaka, Hiroki Yoshimatsu, Yushi Nakanishi, Atsushi Kitamura, Hirotaka Watase,Hideki Suganami, Nobushige Matsuoka, Chihiro Hasegawa

Journal of Pharmacokinetics and Pharmacodynamics(2025)

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关键词
MIDD,Japan,JPMA,Dose selection,Pharmacometrics
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