2013.8 fda指南：anda：原料药和制剂稳定性试验问答(中英文)

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1、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。Commentsandsuggestionsregardingthisdraftdocumentsh

2、ouldbesubmittedwithin60daysofpublicationinthe FederalRegister ofthenoticeannouncingtheavailabilityofthedraftguidance.Submitelectroniccommentsto http://www.regulations.gov.SubmitwrittencommentstotheDivisionofDocketsManagement(HFA-305),FoodandDrugAdministration,5630FishersLane,rm.1061,Rockv

3、ille,MD20852.Allcommentsshouldbeidentifiedwiththedocketnumberlistedinthenoticeofavailabilitythatpublishesinthe FederalRegister.Forquestionsregardingthisdraftdocumentcontact(CDER)RadhikaRajagopalan240-276-8546.U.S. DepartmentofHealthandHumanServicesFoodandDrugAdministrationCenterforDrugEva

4、luationandResearch(CDER)August2013GenericsGuidanceforIndustryANDAs:StabilityTestingofDrugSubstancesandProductsQuestionsandAnswersANDA：原料药和制剂稳定性试验问答Additionalcopiesareavailablefrom:OfficeofCommunicationsDivisionofDrugInformation,WO51,Room2201CenterforDrugEvaluationandResearchFoodandDrugAdm

5、inistration10903NewHampshireAve.,SilverSpring,MD20993Phone:301-796-3400;Fax:301-847-8714druginfo@fda.hhs.govhttp://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/default.htmU.S. DepartmentofHealthandHumanServicesFoodandDrugAdministrationCenterforDrugEvaluationandResea

6、rch(CDER)August2013Generics ContainsNonbindingRecommendations Draft—NotforImplementationTABLEOFCONTENTSI.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.Stability

7、Studies 稳定性试验.GuidanceforIndustry[1]ANDAs:StabilityTestingofDrugSubstancesandProductsQuestionsandAnswersANDA：原料药和制剂稳定性试验问答Thisdraftguidance,whenfinalized,willrepresenttheFoodandDrugAdministration’s(FDA’s)currentthinkingonthistopic.Itdoesnotcreateorconferanyrightsfor