基因毒性杂质限度指南(转载中英文)

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1、20060628EMEA/CHMP/QWP/251344/2006基因毒性杂质限度指南（转载中英文）London,28June2006CPMP/SWP/5199/02EMEA/CHMP/QWP/251344/2006COMMITTEEFORMEDICINALPRODUCTSFORHUMANUSE人用药品委员会(CHMP)GUIDLINEONTHELIMITSOFGENOTOXICIMPURITIES基因毒性杂质限度指南DESCUSSIONINTHESAFETYWORKINGPARTY安全工作组之内的讨论June2002-October

2、2002TRANSMISSIONTOCPMPCPMP传递December2002RELEASEFORCONSULTATION专家讨论December2002DEADLINEFORCOMMENTS建议收集最后期限March2003DISCUSSIONINTHESAFETYWORKINGJune2003-February2004PARTYANDQUALITYWORKINGPARTY安全工作组和质量工作组之间的讨论TRANSMISSIONTOCPMP转移给CPMPMarch2004RE-RELEASEFORCONSULTATION再次放行给

3、顾问团June2004DEADLINEFORCOMMENTS收集意见的最后期限December2004DISCUSSIONINTHESAFETYWORKINGPARTYANDQUALITYWORKINGPARTY安全工作组和质量工作组之间的讨论February2005-May2006ADOPTIONBYCHMP被CHMP采用28June2006DATEFORCOMINGINTOEFFECT生效日期01January2007KEYWORDS关键词Impurities;Genotoxicity;Thresholdoftoxicologic

4、alconcern(TTC);Structureactivityrelationship(SAR)GUIDLINEONTHELIMITSOFGENOTOXICIMPURITIES基因毒性杂质限度指南TABLEOFCONTENTS目录EXECUTIVESUMMARY内容摘要.....................................................................................31.INTRODUCTION介绍................................

5、.................................................................32.SCOPE范围...............................................................................................................................33.LEGALBASIS法律依据...................................................

6、..................................................................34.TOXICOLOGICALBACKGROUND毒理学背景...................................................................................45.RECOMMENDATIONS建议......................................................................

7、.................................45.1GenotoxicCompoundsWithSufficientEvidenceforaThreshold-RelatedMechanism具有充分证据证明其阈值相关机理的基因毒性化合物..........45.2GenotoxicCompoundsWithoutSufficientEvidenceforaThreshold-RelatedMechanism不具备充分证据支持其阈值相关机理的基因毒性化合物.....55.2.1PharmaceuticalAsse

8、ssment药学评价.......................................................................................55.2.2Toxicol