ICH S1前性评估研究和证据权重评估:行业代表的评论
John L Vahle1, Joe Dybowski2, Michael Graziano3
1Lilly Research Laboratories, Indianapolis, IN, United States.
Frontiers in toxicology
|June 7, 2024
概括
国际协调理事会 (ICH) S1B(R1) 准则现在允许证据权重 (WoE) 致癌性评估,减少对两年老鼠研究的需求. 这种评论有助于赞助商在申请 WoE 进行监管提交.
科学领域:
- 药理学和毒理学 药理学和毒理学
- 监管科学 监管科学
- 药物开发 药物开发
背景情况:
- 国际协调理事会 (ICH) S1B指南传统上要求对大鼠进行为期两年的致癌性研究.
- 行业和监管机构合作开发了替代评估策略的附录.
研究的目的:
- 为使用证据权重 (WoE) 方法进行致癌性评估提供指导.
- 协助药物赞助商为监管机构准备关于WoE评估的文件.
- 审查实施挑战,并提供应用WoE标准的案例.
主要方法:
- 开发ICH S1B(R1) 准则的附录.
- 专家工作组 (EWG) 进行前性评估研究 (PES).
- 分析标准的WoE因素和新的调查方法.
主要成果:
- 展望评估研究 (PES) 为制定WoE评估战略提供了经验.
- 该评论为赞助商提供了评估WoE因素和文档的实用建议.
- 案例说明了 WoE 标准的应用,使用以前销售的产品.
结论:
- 新的WoE方法在特定情况下提供了传统的2年老鼠致癌性研究的替代方案.
- 成功实施WoE评估可以提高药物开发的质量和效率.
- 本指南旨在促进监管机构和赞助商通过WoE评估.
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