Article(id=1291404312899474052, tenantId=1146029695717560320, journalId=1246415772164075586, issueId=1291404284806030089, articleNumber=null, orderNo=null, doi=10.13699/j.cnki.1001-6821.2025.04.030, pmid=null, cstr=null, oa=null, hot=null, price=null, onlineType=0, articleFormat=0, articleType=null, articleTypeStr=null, receivedDate=1723651200000, receivedDateStr=2024-08-15, revisedDate=null, revisedDateStr=null, acceptedDate=null, acceptedDateStr=null, onlineDate=1785824381327, onlineDateStr=2026-08-04, pubDate=1740672000000, pubDateStr=2025-02-28, doiRegisterDate=null, doiRegisterDateStr=null, onlineIssueDate=1785824381327, onlineIssueDateStr=2026-08-04, onlineJustAcceptDate=null, onlineJustAcceptDateStr=null, onlineFirstDate=null, onlineFirstDateStr=null, sourceXml=null, magXml=null, createTime=1785824381327, creator=13701087609, updateTime=1785824381327, updator=13701087609, issue=Issue{id=1291404284806030089, tenantId=1146029695717560320, journalId=1246415772164075586, year='2025', volume='41', issue='4', pageStart='451', pageEnd='600', issueExtLink='null', onlineDate='null', pubDate='1740672000000', pubDateStr='2025-02-28', beforeIssueId=null, nextIssueId=null, price=null, status=1, issueComplete=1, articleOrder=1, issueType=-1, specialIssue=null, createTime=1785824374629, creator='13701087609', updateTime=1785824374629, updator='13701087609', preIssue=null, nextIssue=null, articleTotal=null, ext=null, issueFiles=null, downloadFileDto=null}, startPage=596, endPage=600, ext={EN=ArticleExt(id=1291404313117577861, articleId=1291404312899474052, tenantId=1146029695717560320, journalId=1246415772164075586, language=EN, title=Introduction on the addendum to testing for carcinogenicity for pharmaceuticals, columnId=1291339025546211579, journalTitle=Chinese Journal of Clinical Pharmacology, columnName=Drug Evaluation and Administration, runingTitle=null, highlight=null, articleAbstract=

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 S1A “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.

, authors=Yu ZHOU, Fang-hua HUANG, Qing-li WANG, Tao SUN, authorsList=Yu ZHOU, Fang-hua HUANG, Qing-li WANG, Tao SUN, authorCompany=null, correspAuthors=Tao SUN, authorNote=null, correspAuthorsNote=null, copyrightStatement=null, copyrightOwner=null, extLink=null, articleAbsUrl=null, sourceXml=null, magXml=null, pdfUrl=null, pdf=null, pdfFileSize=null, pdfExtLink=null, richHtmlUrl=null, mobilePdfUrl=null, reviewReport=null, pdfFirstPage=null, abstractGraph=null, abstractGraphContent=null, abstractVideo=null, citation=null, cebUrl=null, magXmlContent=null, mapNumber=null, fund=null), CN=ArticleExt(id=1291404313482482310, articleId=1291404312899474052, tenantId=1146029695717560320, journalId=1246415772164075586, language=CN, title=药物致癌性试验指导原则修订情况介绍, columnId=1291339025730760957, journalTitle=中国临床药理学杂志, columnName=药物评价与管理, runingTitle=null, highlight=null, articleAbstract=

药物致癌性试验是支持药物上市的关键毒理学试验，是药物非临床安全性评价的重要内容。人用药品注册技术要求国际协调会（ICH）S1B《药物致癌性试验》就评估药物致癌潜力的方法提供了建议，其中包括开展为期2年的大鼠致癌性试验。随着ICH S1B（R1）《药物致癌性试验指导原则增补》在国内的适用，允许申请人采用证据权重法，而不是常规地进行2年大鼠致癌性试验，以更科学全面的评估ICH S1A《药物致癌性试验必要性指导原则》中规定的某些分子的致癌潜力。该增补文件确定了支持证据权重法评估的关键因素，并强调了调查研究和新兴技术在人体致癌性风险评估中的重要性。本文就ICH S1B（R1）制定的背景信息，主要技术问题以及后续工作进行了讨论，以方便对该指导原则的理解和执行。

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周宇（1986-），男，硕士，主要从事药品技术审评工作

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周宇（1986-），男，硕士，主要从事药品技术审评工作

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