2014年.8fda指南_anda_原料药及制剂稳定性试验问答[中英文]

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1、完美WORD格式资料201308FDA指南：ANDA：原料药和制剂稳定性试验问答（中英文）    GuidanceforIndustry 行业指南ANDAs:StabilityTestingofDrugSubstancesandProductsQuestionsandAnswersANDA：原料药和制剂稳定性试验问答DRAFTGUIDANCE指南草案Thisguidancedocumentisbeingdistributedforcommentpurposesonly.本指南文件发布仅供讨论。Commentsandsuggestionsrega

2、rdingthisdraftdocumentshouldbesubmittedwithin60daysofpublicationinthe FederalRegister ofthenoticeannouncingtheavailabilityofthedraftguidance.Submitelectroniccommentsto http://www.regulations.gov.SubmitwrittencommentstotheDivisionofDocketsManagement(HFA-305),FoodandDrugAdmini

3、stration,5630FishersLane,rm.1061,Rockville,MD20852.Allcommentsshouldbeidentifiedwiththedocketnumberlistedinthenoticeofavailabilitythatpublishesinthe FederalRegister.Forquestionsregardingthisdraftdocumentcontact(CDER)RadhikaRajagopalan240-276-8546.U.S. DepartmentofHealthandHu

4、manServicesFoodandDrugAdministration专业整理分享完美WORD格式资料CenterforDrugEvaluationandResearch(CDER)August2013Generics专业整理分享完美WORD格式资料GuidanceforIndustryANDAs:StabilityTestingofDrugSubstancesandProductsQuestionsandAnswersANDA：原料药和制剂稳定性试验问答Additionalcopiesareavailablefrom:OfficeofCom

5、municationsDivisionofDrugInformation,WO51,Room2201CenterforDrugEvaluationandResearchFoodandDrugAdministration10903NewHampshireAve.,SilverSpring,MD20993Phone:301-796-3400;Fax:301-847-8714druginfo@fda.hhs.govhttp://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Guid

6、ances/default.htmU.S. DepartmentofHealthandHumanServicesFoodandDrugAdministrationCenterforDrugEvaluationandResearch(CDER)August2013Generics ContainsNonbindingRecommendations Draft—NotforImplementation专业整理分享完美WORD格式资料TABLEOFCONTENTSI.INTRODUCTION 介绍II.QUESTIONSANDANSWERS 问与答A

7、.General 一般问题B.DrugMasterFile 药物主文件.C.DrugProductManufacturingandPackaging 药品生产和包装D.AmendmentstoPendingANDAApplication 未批准ANDA申请的增补E.StabilityStudies 稳定性试验.专业整理分享完美WORD格式资料GuidanceforIndustry[1]ANDAs:StabilityTestingofDrugSubstancesandProductsQuestionsandAnswersANDA：原料药和制剂稳定

8、性试验问答Thisdraftguidance,whenfinalized,willrepresenttheFoodandDrugAdministrat