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时间:2018-11-28
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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Q8RecommendedforAdoptionatStep4o
2、ftheICHProcesson10November2005bytheICHSteeringCommittee ICH指导委员会2005年11月10日ICH第四阶段推荐采用 ThisGuidelinehasbeendevelopedbytheappropriateICHExpertWorkingGroupandhasbeensubjecttoconsultationbytheregulatoryparties,inaccordancewiththeICHProcess. AtStep4oftheProcessthefinaldraf
3、tisrecommendedforadoptiontotheregulatorybodiesoftheEuropeanUnion,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 ObjectiveoftheGuideline指南目的...11.2 Scope范围...12. PHARMACEUTICALDEVEL
4、OPMENT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...52.2.2 Overages超量...62.2.3 PhysicochemicalandBiologicalProperties物化和生化性质...72.3 Manuf
5、acturingProcessDevelopment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. GLOSSARY术语...111. INTRODUCTION简介1.1ObjectiveofGuideline指南目的Thisguidelinedescribesthesuggestedcontentsforthe3.2.P.2(Pharmac
6、euticalDevelopment)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给出了建议。ThePharmaceuticalDevelopmentsectionprovidesanopportunitytopresenttheknowledgegainedthroughtheapplicationofscientificapproachesandqualityri
7、skmanagement(fordefinition,seeICHQ9)tothedevelopmentofaproductanditsmanufacturingprocess.Itisfirstproducedfortheoriginalmarketingapplicationandcanbeupdatedtosupportnewknowledgegainedoverthelifecycleofaproduct.ThePharmaceuticalDevelopmentsectionisintendedtoprovideacomprehens
8、iveunderstandingoftheproductandmanufacturingprocessforreviewersandinspectors.Thegu
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