ich-q8(中英文)

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1、ICHQ8（中英文）blueski推荐 [2009-12-20]出处：Julia的blog作者：不详 INTERNATIONALCONFERENCEONHARMONISATIONOFTECHNICALREQUIREMENTSFORREGISTRATIONOFPHARMACEUTICALSFORHUMANUSE人用药物注册技术要求国际协调会议ICHHarmonisedTripartiteGuideline ICH三方协调指南PharmaceuticalDevelopment药物开发Q8Recomm

2、endedforAdoptionatStep4oftheICHProcesson10November2005bytheICHSteeringCommittee     ICH指导委员会2005年11月10日ICH第四阶段推荐采用  ThisGuidelinehasbeendevelopedbytheappropriateICHExpertWorkingGroupandhasbeensubjecttoconsultationbytheregulatoryparties,inaccordancewi

3、ththeICHProcess. AtStep4oftheProcessthefinaldraftisrecommendedforadoptiontotheregulatorybodiesoftheEuropeanUnion,JapanandUSA.本指南根据ICH规程由合适的ICH专家工作组起草并经向法规部门咨询。在规程的第4步，建议欧洲共同体、日本和美国的药政部门采用其最终的草案。 TABLEOFCONTENTS目录 1.      INTRODUCTION简介...11.1    Obje

4、ctiveoftheGuideline指南目的...11.2    Scope范围...12.      PHARMACEUTICALDEVELOPMENT药物开发...12.1    ComponentsoftheDrugProduct制剂产品的组分...42.1.1     DrugSubstance活性成分...42.1.2     Excipients辅料...42.2    DrugProduct制剂...52.2.1     FormulationDevelopment配方开发...

5、52.2.2     Overages超量...62.2.3     PhysicochemicalandBiologicalProperties物化和生化性质...72.3    ManufacturingProcessDevelopment制造工艺开发...72.4    ContainerClosureSystem容器系统...92.5    MicrobiologicalAttributes微生物属性...92.6    Compatibility兼容性...103.      GLOS

6、SARY术语...111.   INTRODUCTION简介1.1ObjectiveofGuideline指南目的Thisguidelinedescribesthesuggestedcontentsforthe3.2.P.2(PharmaceuticalDevelopment)sectionofaregulatorysubmissionintheICHM4CommonTechnicalDocument(CTD)format. 本指南就CTD格式申请文件中第3.2.P.2章：药物开发需要叙述的内容

7、给出了建议。ThePharmaceuticalDevelopmentsectionprovidesanopportunitytopresenttheknowledgegainedthroughtheapplicationofscientificapproachesandqualityriskmanagement(fordefinition,seeICHQ9)tothedevelopmentofaproductanditsmanufacturingprocess.Itisfirstproduced

8、fortheoriginalmarketingapplicationandcanbeupdatedtosupportnewknowledgegainedoverthelifecycleofaproduct.ThePharmaceuticalDevelopmentsectionisintendedtoprovideacomprehensiveunderstandingoftheproductandmanufacturingprocessforreviewersandinspectors.Thegu