预览加载中，请您耐心等待几秒...

ACTD目录.docx

预览
1/6
2/6
3/6
4/6
5/6
6/6

在线预览结束，喜欢就下载吧，查找使用更方便

下载提示 文本预览

如果您无法下载资料，请参考说明：

1、部分资料下载需要金币，请确保您的账户上有足够的金币

2、已购买过的文档，再次下载不重复扣费

3、资料包下载后请先用软件解压，在使用对应软件打开

A-DRUGSUBSTANCE S1.GeneralInformation S.1.1Nomenclature S.1.2Structuralformula S.1.3GeneralProperties S2.Manufacture S2.1Manufacturer(s) S2.2DescriptionofMfg.ProcessandProcessControls S2.3ControlofMaterials S2.4ControlofCriticalStepsandIntermediates S2.5Processvalidationand/orEvaluation S2.6ManufacturingProcessDevelopment S3.Characterization S3.1Elucidationofstructure&characteristics S3.2Impurities S4.ControlofDrugSubstance S4.1Specification S4.2AnalyticalProcedure S4.3ValidationofAnalyticalProcedures S4.4BatchAnalysis S4.5JustificationofSpecification S5.ReferenceStandardsorMaterials S6.ContainerClosureSystem S7.Stability StabilitySummary&Conclusion Post-approvalStabilityProtocol&StabilityCommiment StabilitySummaryData B-DRUGPRODUCT P1.DescriptionandComposition P2.PharmaceuticalDevelopment P2.1InformationonDevelopmentStudies P2.2ComponentofDrugProduct P2.2.1Activeingredient P2.2.2Excipients P2.3Finishedproduct P2.3.1FormulationDevelopment P2.3.2Overages P2.3.3PhysicochemicalandBiologicalProperties P2.4ManufacturingProcessDevelopment P2.5ContainerClosureSystem P2.6MicrobiologicalAttributes P2.7Compatibility P3.Manufacture P3.1Batchformula P3.2ManufacturingProcessandProcessControl P3.3ControlsofCriticalStepsandIntermediates P3.4ProcessValidationand/orEvaluation P4.ControlofExcipients P4.1Specification P4.2AnalyticalProcedures P4.3ExcipientsofHumanandAnimalOrigin P4.4NovelExcipients P5.ControlofDrug(Finished)Product P5.1Specification P5.2AnalyticalProcedure P5.3ValidationofAnalyticalProcedure P5.4BatchAnalysis P5.5CharacterizationofImpurities P5.6JustificationofSpecification P6.ReferenceStandardsorMaterials P7.ContainerClosureSystem P8.Stability StabilitySummaryandConclusion Post-approvalstabilityandstabilitycommitment Stabilitydata P9.ProductInterchangeability TableofContents MODULE1:ADMINISTRATIVEINFORMATIONANDPRESCRIBINGINFORMATION 1.0Coverletter 1.1Tableofcontentsoftheapplicationincludingmodule1(module1-5) 1.2Applicationinformation 1.3Prescribinginformation 1.4Samp