中国临床药理学杂志2025，Vol.41Issue(4)：596-600,5.DOI:10.13699/j.cnki.1001-6821.2025.04.030
药物致癌性试验指导原则修订情况介绍
Introduction on the addendum to testing for carcinogenicity for pharmaceuticals
周宇 1黄芳华 1王庆利 1孙涛1
作者信息
- 1. 国家药品监督管理局药品审评中心,北京 100022
- 折叠
摘要
Abstract
Testing for carcinogenicity is a key toxicological test that supports marketing authorization and an important part of nonclinical safety studies for pharmaceuticals.International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use(ICH)S1B"Testing for carcinogenicity of pharmaceuticals"provides recommendations on approaches for evaluating the carcinogenic potential of pharmaceuticals which can include the conduct of a 2-year rat carcinogenicity study.With the application of the ICH S1B(R1)"Addendum to testing for carcinogenicity for pharmaceuticals"in China,sponsors are allowed to use the weight of evidence(WoE)method rather than the conventional 2-year rat carcinogenicity study,a more scientific and comprehensive assessment of the carcinogenic potential of certain molecules specified in ICH S1 A"Guideline on the need for carcinogenicity studies of pharmaceuticals".This addendum identifies key factors supporting WoE assessment and emphasizes the importance of survey investigative studies and emerging technology in assessing human carcinogenic risks.This article discusses the background information on the development of ICH S1B(R1),main technical issues,and follow-up work,in order to facilitate the understanding and implementation of this guideline.关键词
致癌性试验/证据权重法/致癌性评估/药物Key words
testing for carcinogenicity/weight-of-evidence approach/carcinogenicity risk assessment/pharmaceutical分类
药学引用本文复制引用
周宇,黄芳华,王庆利,孙涛..药物致癌性试验指导原则修订情况介绍[J].中国临床药理学杂志,2025,41(4):596-600,5.
