ICH Q12「医薬品のライフサイクルマネジメントにお ける技 …
ich q12を活用するにあたって 5 ich q12はすでに発行されているich q8(r2)、ich q9、ich q10、ich q11を含むその他のich品質領域のガイドラインと の併用が望ましい 申請書(ctd)の記載箇所については本ガイドラインの3章、4章、 5章を参照し、適切な記載を推奨する
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