美国FDA/CDER/OND对新方法方法 (NAMs) 的经验

Jia Yao¹, Jackye Peretz¹, Ilona Bebenek¹

¹Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, MD, USA.

International journal of toxicology

|November 13, 2025

概括

美国食品和药物管理局 (FDA) 鼓励新方法方法 (NAMs) 用于药物安全测试. 这个视角详细介绍了NAM的历史整合,审查员的见解和未来的方向,以推进监管科学和保护公共健康.

科学领域:

监管科学监管科学
毒理学毒理学毒理学
药物开发药物开发

背景情况:

美国食品和药物管理局的药物评估和研究中心 (CDER) 积极促进在非临床测试中使用新方法方法 (NAMs).
以前的FDA / CDER出版物已经解决了药物开发当前非临床测试方法的战略,挑战和差距.
通过采用NAMs,不断努力改进,减少和取代动物试验.

研究的目的:

为了证明NAMs在FDA/CDER标准非临床评估中的历史纳入.
提供CDER/新药局 (OND) 药理学/毒理学审查员对评估NAM提交的新药开发的见解.
概述未来将NAM整合到非临床药物开发计划中,以反映不断发展的科学技术.

主要方法:

对FDA/CDER关于验证和接受NAM作为动物试验替代品的历史实践的审查.
汇编了CDER/OND药理学/毒理学审查人员对提交的NAM数据进行监管决策的观点.
对当前趋势的分析以及将NAM纳入非临床药物安全评估的未来考虑.

主要成果:

特定的NAM已经成功验证并被接受为国际公认的动物试验替代品,用于监管目的.
美国食品和药物管理局/CDER在评估NAM提交时采用了结构化的科学方法,确保科学严谨性和监管合规性.
审查员的经验凸显了NAM在支持新药的安全性和有效性方面的实用性和挑战.

结论:

美国食品和药物管理局/CDER/OND致力于通过战略性纳入NAM来实现动物试验中的3R (替代,减少,改进).
分享经验和提供关于NAM提交的指导旨在促进对监管评估流程的信心.
持续鼓励NAM提交支持FDA保护公共健康的使命,同时推进创新药物开发.

关键词:

美国食品和药物管理局/CDER/OND.在体内非人体试验.创新的药物开发创新的药物开发.新方法方法论 (NAMs)非临床试验的试验.药理学/毒理学药理学/毒理学

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