ichm7(step4)基因毒性杂质评估和控制◆中英

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1、word资料下载可编辑ASSESSMENTAND CONTROLOF DNAREACTIVE(MUTAGENIC)IMPURITIESIN PHARMACEUTICALSTOLIMIT POTENTIAL CARCINOGENIC RISK为限制潜在致癌风险而对药物中DNA活性（诱变性）杂质进行的评估和控制M7Current Step4 versiondated23June2014ThisGuidelinehasbeendevelopedbytheappropriateICHExpertWorkingGroupandhasbeensubj

2、ecttoconsultationbytheregulatoryparties,inaccordancewiththeICHProcess.AtStep4oftheProcessthefinaldraftisrecommendedforadoptiontotheregulatorybodiesoftheEuropeanUnion,JapanandUSA.专业技术资料word资料下载可编辑 M7DocumentHistory 文件历史Code 文件代码History 历史Date 日期M7ApprovalbytheSteeringCommi

3、tteeunderStep2andreleaseforpublicconsultation.第2阶段由筹委会批准，公开征求意见6February2013M7ApprovalbytheSteeringCommitteeunderStep4andrecommendationforadoptiontothethreeICHregulatorybodies.第4阶段由筹委会批准，推荐ICH三方药监局采用5June2014CurrentStep4version 现行版本第4阶段M7Corrigendumtofixtypographicalerror

4、sandreplaceword“degradants”with“degradationproducts”throughoutthedocument.修正输入错误，将全文中“degradants”替换成“degradationproducts”.23June2014 LegalNotice: Thisdocumentisprotectedbycopyrightandmaybeused,reproduced,incorporatedintootherworks,adapted,modified,translatedordistributedu

5、nderapubliclicenseprovidedthatICH'scopyrightinthedocumentisacknowledgedatalltimes.Incaseofanyadaption,modificationortranslationofthedocument,reasonablestepsmustbetakentoclearlylabel,demarcateorotherwiseidentifythatchangesweremadetoorbasedontheoriginaldocument.Anyimpressio

6、nthattheadaption,modificationortranslationoftheoriginaldocumentisendorsedorsponsoredbytheICHmustbeavoided.专业技术资料word资料下载可编辑Thedocumentisprovided"asis"withoutwarrantyofanykind.InnoeventshalltheICHortheauthorsoftheoriginaldocumentbeliableforanyclaim,damagesorotherliabilitya

7、risingfromtheuseofthedocument.Theabove-mentionedpermissionsdonotapplytocontentsuppliedbythirdparties.Therefore,fordocumentswherethecopyrightvestsinathirdparty,permissionforreproductionmustbeobtainedfromthiscopyrightholder.专业技术资料word资料下载可编辑ASSESSMENTAND CONTROLOF DNAREACTI

8、VE (MUTAGENIC)IMPURITIESIN PHARMACEUTICALSTO LIMIT POTENTIALCARCINOGENIC RISK为限制潜在致癌风险而对药物中DNA活性