文档介绍：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 mittee     ICH指导委员会2005年11月10日ICH第四阶段推荐采用  ThisGuidelinehasbeendevelopedbytheappropriateICHExpertWorkingGroupandhasbeensubjecttoconsultationbytheregulatoryparties,ordancewiththeICHProcess. mendedforadoptiontotheregulatorybodiesoftheEuropeanUnion,。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...    ObjectiveoftheGuideline指南目的...    Scope范围...12.      PHARMACEUTICALDEVELOPMENT药物开发...    ComponentsoftheDrugProduct制剂产品的组分...     DrugSubstance活性成分...     Excipients辅料...    DrugProduct制剂...     FormulationDevelopment配方开发...     Overages超量...     PhysicochemicalandBiologicalProperties物化和生化性质...    ManufacturingProcessDevelopment制造工艺开发...    ContainerClosureSystem容器系统...    MicrobiologicalAttributes微生物属性...    Compatibility兼容性...103.      GLOSSARY术语...111.   (PharmaceuticalDevelopment)monTechnicalDocument(CTD)format. :药物开发需要叙述的内容给出了建议。ThePharmaceuticalDevelopmentsectionprovidesanopportunitytopresenttheknowledgegainedthroughtheapplicationofscientificapproachesandqualityriskmanagement(fordefinition,seeICHQ9)