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小児領域の医薬品開発における現状と ... - Pmda
ICH E11 Guideline Clinical Investigation of Medicinal Products in the Pediatric Population ICH：International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use（医薬品規制調和国際会議） 小児集団における医薬品の臨床試験に関するガイダンス
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