FDA新指南：仿制药(原料药)中的杂质研究(英文).pdf

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1、如果想要下载更多的资源请百度一下药智论坛GuidanceforIndustryANDAs:ImpuritiesinDrugSubstancesU.S.DepartmentofHealthandHumanServicesFoodandDrugAdministrationCenterforDrugEvaluationandResearch(CDER)June2009OfficeofGenericDrugsRevision1本资料由药智论坛收集整理，仅供学习使用，任何单位或个人不得用于商业用途如果想要下载更多的资源请百度一下药智论坛GuidanceforIndu

2、stryANDAs:ImpuritiesinDrugSubstancesAdditionalcopiesareavailablefrom:OfficeofCommunicationDivisionofDrugInformation,WO51,Room2201CenterforDrugEvaluationandResearchFoodandDrugAdministration10903NewHampshireAve.SilverSpring,MD20993-0002Phone:301-796-3400;Fax:301-847-8715druginfo@fda

3、.hhs.govU.S.DepartmentofHealthandHumanServicesFoodandDrugAdministrationCenterforDrugEvaluationandResearch(CDER)June2009OfficeofGenericDrugsRevision1本资料由药智论坛收集整理，仅供学习使用，任何单位或个人不得用于商业用途如果想要下载更多的资源请百度一下药智论坛TABLEOFCONTENTSI.INTRODUCTION.................................................

4、............................................................1II.BACKGROUND...............................................................................................................2III.LISTINGIMPURITIESANDSETTINGACCEPTANCECRITERIAFORIMPURITIESINDRUGSUBSTANCESPECIFICATIONS....

5、..................................2A.ListingImpuritiesinDrugSubstanceSpecifications..................................................................2B.SettingAcceptanceCriteriaforImpurities.................................................................................3IV.QUALIF

6、ICATIONOFIMPURITIES............................................................................4A.QualificationThresholds...............................................................................................................5B.QualificationProcedures.......................

7、........................................................................................51.ComparativeAnalyticalStudies.......................................................................................................52.ScientificLiteratureandSignificantMetabolites...........

8、.................................