S04-02 ICHS1B附录的实施：监管的观点

IF 2.9 3区医学 Q2 TOXICOLOGY

Toxicology letters Pub Date : 2025-09-01 DOI:10.1016/j.toxlet.2025.07.055

K. Siezen

{"title":"S04-02 ICHS1B附录的实施：监管的观点","authors":"K. Siezen","doi":"10.1016/j.toxlet.2025.07.055","DOIUrl":null,"url":null,"abstract":"<div><div>Since the revision of ICH S1B has come into effect in 2022, several Weight of Evidence documents have been submitted to regulatory authorities, to establish the risk of a carcinogenic effect of a medicinal product, and the need for a 2-year rat study to further investigate this risk. An overview will be provided, illustrating how many and to which authorities WoE approaches are submitted, and what proportion is accepted or denied. Further an analysis of reasons why such decisions were made is provided. Any discrepancies between regulatory agencies on the decision of accepting or denying the WoE will be presented and discussed further.</div></div>","PeriodicalId":23206,"journal":{"name":"Toxicology letters","volume":"411 ","pages":"Pages S17-S18"},"PeriodicalIF":2.9000,"publicationDate":"2025-09-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":"0","resultStr":"{\"title\":\"S04-02 Implemetation of ICHS1B addendum: a regulatory point of view\",\"authors\":\"K. Siezen\",\"doi\":\"10.1016/j.toxlet.2025.07.055\",\"DOIUrl\":null,\"url\":null,\"abstract\":\"<div><div>Since the revision of ICH S1B has come into effect in 2022, several Weight of Evidence documents have been submitted to regulatory authorities, to establish the risk of a carcinogenic effect of a medicinal product, and the need for a 2-year rat study to further investigate this risk. An overview will be provided, illustrating how many and to which authorities WoE approaches are submitted, and what proportion is accepted or denied. Further an analysis of reasons why such decisions were made is provided. Any discrepancies between regulatory agencies on the decision of accepting or denying the WoE will be presented and discussed further.</div></div>\",\"PeriodicalId\":23206,\"journal\":{\"name\":\"Toxicology letters\",\"volume\":\"411 \",\"pages\":\"Pages S17-S18\"},\"PeriodicalIF\":2.9000,\"publicationDate\":\"2025-09-01\",\"publicationTypes\":\"Journal Article\",\"fieldsOfStudy\":null,\"isOpenAccess\":false,\"openAccessPdf\":\"\",\"citationCount\":\"0\",\"resultStr\":null,\"platform\":\"Semanticscholar\",\"paperid\":null,\"PeriodicalName\":\"Toxicology letters\",\"FirstCategoryId\":\"3\",\"ListUrlMain\":\"https://www.sciencedirect.com/science/article/pii/S0378427425016388\",\"RegionNum\":3,\"RegionCategory\":\"医学\",\"ArticlePicture\":[],\"TitleCN\":null,\"AbstractTextCN\":null,\"PMCID\":null,\"EPubDate\":\"\",\"PubModel\":\"\",\"JCR\":\"Q2\",\"JCRName\":\"TOXICOLOGY\",\"Score\":null,\"Total\":0}","platform":"Semanticscholar","paperid":null,"PeriodicalName":"Toxicology letters","FirstCategoryId":"3","ListUrlMain":"https://www.sciencedirect.com/science/article/pii/S0378427425016388","RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"","PubModel":"","JCR":"Q2","JCRName":"TOXICOLOGY","Score":null,"Total":0}

引用次数: 0

摘要

自ICH S1B修订于2022年生效以来，已向监管机构提交了几份证据权重文件，以确定药品的致癌作用风险，并需要进行为期2年的大鼠研究以进一步调查这一风险。将提供概述，说明有多少和哪些机构提交了WoE方法，以及接受或拒绝的比例。进一步分析了作出这种决定的原因。监管机构之间在接受或拒绝《责任清单》的决定上的任何差异将被提出并进一步讨论。

本文章由计算机程序翻译，如有差异，请以英文原文为准。

查看原文本刊更多论文

S04-02 Implemetation of ICHS1B addendum: a regulatory point of view

Since the revision of ICH S1B has come into effect in 2022, several Weight of Evidence documents have been submitted to regulatory authorities, to establish the risk of a carcinogenic effect of a medicinal product, and the need for a 2-year rat study to further investigate this risk. An overview will be provided, illustrating how many and to which authorities WoE approaches are submitted, and what proportion is accepted or denied. Further an analysis of reasons why such decisions were made is provided. Any discrepancies between regulatory agencies on the decision of accepting or denying the WoE will be presented and discussed further.

求助全文

通过发布文献求助，成功后即可免费获取论文全文。去求助

来源期刊