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ICH S4 動物での慢性毒性研究の期間

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November 10, 2020
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ICH S4 動物での慢性毒性研究の期間

ICH S4は動物で実施する慢性毒性研究の期間についてのガイドラインです。

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xjorv

November 10, 2020

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Transcript

  1. ICH S4 動物での慢性毒性研究の期間 2020/11/5 Ver. 1.0

  2. ガイドラインの概要 有効成分の慢性毒性＊を調べる方法について • げっ歯類、非げっ歯類での試験について • げっ歯類では6ヶ月試験実施で3局調和されていた • 非げっ歯類での試験期間を9ヶ月に定める ＊Chronic toxicity