ICH 系列指导原则VIP免费

ICH：Quality质量Q1A(R2):StabilityTestingofNewDrugSubstancesandProducts(SecondRevision)新原料药和制剂的稳定性试验（第二版）Q1B:PhotostabilityTestingofNewDrugSubstancesandProducts新原料药和制剂的光稳定性试验Q1C:StabilityTestingforNewDosageForms新制剂的稳定性试验Q1D:BracketingandMatrixingDesignsforStabilityTestingofDrugSubstancesandDrugProducts原料药和制剂稳定性试验的交叉和矩阵设计Q1E:EvaluationofStabilityData对稳定性数据的评估处理Q1F:StabilityDataPackageforRegistrationApplicationsinClimaticZonesIIIandIV在气候带III和IV，药物注册申请所提供的稳定性数据Q2A:TextonValidationofAnalyticalProcedures分析程序的验证Q2B:ValidationofAnalyticalProcedures:Methodology分析程序的验证：方法学Q3A(R):ImpuritiesinNewDrugSubstances(RevisedGuideline)新原料药中的杂质（修订版）Q3B(R):ImpuritiesinNewDrugProducts(RevisedGuideline)新制剂中的杂质（修订版）Q3C:Impurities:GuidelineforResidualSolvents杂质：残留溶剂指南Q3C(M):Impurities:GuidelineforResidualSolvents(Maintenance)杂质：残留溶剂指南（修改内容）Q4:Pharmacopoeias药典Q4A:PharmacopoeialHarmonisation药典的协调Q4B:RegulatoryAcceptanceofPharmacopoeialInterchangeability药典互替在法规上的可接受性Q5A:ViralSafetyEvaluationofBiotechnologyProductsDerivedfromCellLinesofHumanorAnimalOrigin来源于人或者动物细胞系的生物技术产品的病毒安全性评估Q5B:QualityofBiotechnologicalProducts:AnalysisoftheExpressionConstructinCellsUsedforProductionofr-DNADerivedProteinProducts生物技术产品的质量：源于重组DNA的蛋白质产品的生产中所用的细胞中的表达构建分析Q5C:QualityofBiotechnologicalProducts:StabilityTestingofBiotechnological/BiologicalProducts生物技术产品的质量：生物技术/生物产品的稳定性试验Q5D:DerivationandCharacterisationofCellSubstratesUsedforProductionofBiotechnological/BiologicalProducts用于生产生物技术/生物产品的细胞底物的起源和特征描述Q5E:ComparabilityofBiotechnological/BiologicalProductsSubjecttoChangesinTheirManufacturingProcess基于不同生产工艺的生物技术产品/生物产品的可比较性Q6:SpecificationsforNewDrugSubstancesandProducts新原料药和制剂的质量规格Q6A:Specifications:TestProceduresandAcceptanceCriteriaforNewDrugSubstancesandNewDrugProducts:ChemicalSubstances质量规格：新原料药和新制剂的检验程序和可接收标准：化学物质Q6B:Specifications:TestProceduresandAcceptanceCriteriaforBiotechnological/BiologicalProducts质量规格：生物技术/生物产品的检验程序和可接收标准Q7:GoodManufacturingPracticesforPharmaceuticalIngredients活性药物成份的GMPQ7A:GoodManufacturingPracticeGuideforActivePharmaceuticalIngredients活性药物成份的GMP指南Q8:PharmaceuticalDevelopment药物研发Q9:QualityRiskManagement质量风险管理ICH：Safety安全S1A:GuidelineontheNeedforCarcinogenicityStudiesofPharmaceuticals药物致癌性研究需要的指南S1B:TestingforCarcinogenicityofPharmaceuticals药物致癌性的检验S1C:DoseSelectionforCarcinogenicityStudiesofPharmaceuticals药物致癌性研究之剂量选择S1C(R):Addendum:AdditionofaLimitDoseandRelatedNotes附录：极限剂量和有关注释的的补充S2A:GuidanceonSpecificAspectsofRegulatoryGenotoxicityTestsforPharmaceuticals受法规管辖的药物基因毒性检验的特定方面的指南S2B:Genotoxicity:AStandardBatteryforGenotoxicityTestingforPharmaceuticals基因毒性：药物基因毒性检验的标准S3A:NoteforGuidanceonToxicokinetics:TheAssessmentofSystemicExposureinToxicityStudies毒物代谢动力学指南的注释：毒性研究中的全身性暴露量的评估S3B:Pharmacokinetics:GuidanceforRepeatedDoseTissueDistributionStudies药物代谢动力学：重复剂量的组织分布研...