创新药(化学药)Ⅲ期临床试验药学研究信息指南

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1/S.1S.1.1INNS.1.22/S.1.3BCSpkaLogP/LogDS.2S.2.1S.2.212/S.2.3/3TSE/BSES.2.4S.2.5S.2.6I/IIS.3S.3.1X//4S.3.2//TSE/BSES.4S.4.1HPLCS.4.2S.4.35S.4.4/S.4.5/S.5S.6S.76//NDAP.1P.27////P.3P.3.1P.3.28P.3.3P.3.4P.3.5/P.4Ch.PUSPPh.EurJP/TSE/BSE9P.5P.5.1HPLC/pHP.5.2P.5.3P.5.4/P.5.5S.3.2/10P.5.6/P.6S.5P.7P.811/NDA0.9%121.12/34567892.12%1323425KGy1.EMA2016Guidelineontherequirementstothechemicalandpharmaceuticalqualitydocumentationconcerninginvestigationalmedicinalproductsinclinicaltrialsdraft.2.FDA2003GuidanceforIndustryINDsforPhase2andPhase3StudiesChemistryManufacturingandControlsInformation.3.FDA1995GuidanceforIndustryContentandFormatofInvestigationalNewDrugApplicationsINDsforPhase1StudiesofDrugsIncludingWell-CharacterizedTherapeuticBiotechnology-derivedProducts.4.FDA2008GuidanceforIndustryCGMPforPhase1InvestigationalDrugs.5.EMA2014Guidelineonprocessvalidationforfinishedproductsinformationanddatatobeprovidedinregulatorysubmissions.6.ICH2014M7AssessmentandControlOfDNAReactiveMutagenicImpuritiesinPharmaceuticalstoLimitPotentialCarcinogenicRisk7.14201538.20161349.2016155

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