fda指南设计：anda原料药和制剂稳定性试验问答201805

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1、实用标准文案201405FDA指南：ANDA：原料药和制剂稳定性试验问答GuidanceforIndustry行业指南ANDAs:StabilityTestingofDrugSubstancesandProductsQuestionsandAnswersANDA：原料药和制剂稳定性试验问答FinalGUIDANCE最终稿指南U.S.DepartmentofHealthandHumanServicesFoodandDrugAdministrationCenterforDrugEvaluationandResearch(CDER)May2014Generics精彩文档

2、实用标准文案GuidanceforIndustryANDAs:StabilityTestingofDrugSubstancesandProductsQuestionsandAnswersANDA：原料药和制剂稳定性试验问答Additionalcopiesareavailablefrom:OfficeofCommunicationsDivisionofDrugInformation,WO51,Room2201CenterforDrugEvaluationandResearchFoodandDrugAdministration10903NewHampshireAve.

3、,SilverSpring,MD20993Phone:301-796-3400;Fax:301-847-8714druginfo@fda.hhs.govU.S.DepartmentofHealthandHumanServicesFoodandDrugAdministrationCenterforDrugEvaluationandResearch(CDER)May2014Generics精彩文档实用标准文案TABLEOFCONTENTS目录I.INTRODUCTION介绍II.QUESTIONSANDANSWERS提问和回答A.General一般问题B.DrugMa

4、sterFile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.精彩文档实用标准文案GuidanceforIndustryANDAs:StabilityTestingofDrugSubstancesandProductsQuestionsandAnswersANDA：原料药和制剂稳定性试验问答ThisguidancerepresentstheFoodandDrugAdm

5、inistration’s(FDA’s)currentthinkingonthistopic.ItdoesnotcreateorconferanyrightsfororonanypersonanddoesnotoperatetobindFDAorthepublic.Youcanuseanalternativeapproachiftheapproachsatisfiestherequirementsoftheapplicablestatutesandregulations.Ifyouwanttodiscussanalternativeapproach,contact

6、theFDAstaffresponsibleforimplementingthisguidance.IfyoucannotidentifytheappropriateFDAstaff,calltheappropriatenumberlistedonthetitlepageofthisguidance.本指南代表的是FDA目前对这一专题的态度。它并未建立或赋予任何个人任何权利，并不与FDA或公众有任何绑定。你可以使用任何一种替代方法，只要所用的方法满足成文的法规要求。如果你想要讨论一个替代方法，请与FDA负责实施本指南的相关人员联系。如果你无法识别要联系的人，可以拨

7、打本指南首页所列的相应的电话号。I.INTRODUCTION介绍ThisguidanceprovidesanswerstoquestionsfromthepubliccommentswereceivedonthedraftguidanceforindustryonANDAs:StabilityTestingofDrugSubstancesandProducts(stabilityguidance)thatpublishedonSeptember25,2012.ThefinalguidanceforindustryofthesametitlepublishedonJ

8、une20