医薬品の発達毒性を評価するための新しいアプローチの方法論:事例例と将来の方向

Nicola Powles-Glover¹, Allen R Kaczor², Steven Van Cruchten³

¹currently ExxonMobil, Houston, TX, USA (RSA Associates, at time of writing).

Reproductive toxicology (Elmsford, N.Y.)

|August 30, 2025

まとめ

発達性毒性 (Dev Tox) 検査のための新しいアプローチ方法論 (NAM) は有望ですが,規制上の障害に直面しています. NAMのデータ共有と理解の強化

科学分野:

薬理学と毒理学
生殖と発達生物学

背景:

開発毒性 (Dev Tox) 試験のための新アプローチ方法論 (NAM) は,薬剤開発においてますます使用されています.
Dev Toxのリスク評価のためのNAMの規制承認は,発達の複雑さと母と薬剤の相互作用のために困難です.

研究の目的:

開発毒性リスク評価におけるNAMの規制採用における課題と機会を調査する.
製薬会社によるNAMの提出と認定を妨げている要因を特定する.

主な方法:

Dev ToxのNAMに関する現在の規制ガイドラインのレビュー (ICH S5修正3)
NAMの規制上の資格と使用に影響を与える要因の分析

主要な成果:

保健当局は,ICH S5に記載されているように,Dev Tox NAMがリスク評価に役立つ特定の文脈を認識しています.
製薬会社は生物学的理解,適用性,データの可視性に関する懸念のために,Dev Tox NAMを規制資格のために提出することはめったにありません.

結論:

NAMの生物学的関係,適用領域,および翻訳性のさらなる理解は,規制当局の承認に不可欠です.
Dev Tox NAMの利用を規制の意思決定に容易にするため,業界と保健当局の間でデータ共有の強化が必要である.

キーワード:

3Rs について NAM について代替品開発発達生物学薬剤毒性について

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