2013.8fda指南_anda_原料药和制剂稳定性试验问答(中英文)

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1、WORD格式整理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。Commentsandsuggest

2、ionsregardingthisdraftdocumentshouldbesubmittedwithin60daysofpublicationinthe FederalRegister ofthenoticeannouncingtheavailabilityofthedraftguidance.Submitelectroniccommentsto http://www.regulations.gov.SubmitwrittencommentstotheDivisionofDocketsManagement(HFA-305)

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

4、U.S. DepartmentofHealthandHumanServicesFoodandDrugAdministration专业资料值得拥有WORD格式整理CenterforDrugEvaluationandResearch(CDER)August2013Generics专业资料值得拥有WORD格式整理GuidanceforIndustryANDAs:StabilityTestingofDrugSubstancesandProductsQuestionsandAnswersANDA：原料药和制剂稳定性试验问答Additi

5、onalcopiesareavailablefrom:OfficeofCommunicationsDivisionofDrugInformation,WO51,Room2201CenterforDrugEvaluationandResearchFoodandDrugAdministration10903NewHampshireAve.,SilverSpring,MD20993Phone:301-796-3400;Fax:301-847-8714druginfo@fda.hhs.govhttp://www.fda.gov/Dr

6、ugs/GuidanceComplianceRegulatoryInformation/Guidances/default.htmU.S. DepartmentofHealthandHumanServicesFoodandDrugAdministrationCenterforDrugEvaluationandResearch(CDER)August2013Generics ContainsNonbindingRecommendations Draft—NotforImplementation专业资料值得拥有WORD格式整理T

7、ABLEOFCONTENTSI.INTRODUCTION 介绍II.QUESTIONSANDANSWERS 问与答A.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.专业资料值得拥有WORD格式整理GuidanceforIndustry[1]ANDAs:Stabili

8、tyTestingofDrugSubstancesandProductsQuestionsandAnswersANDA：原料药和制剂稳定性试验问答Thisdraftguidance,whenfinalized,willrepresenttheFoodandDrugAdministratio