Bioequivalence Studies Pharmacokinetic Endpoints for Drugs withSubmitted Under an ANDA 生物等效性研究 药物地药代动力学终点 安达提交.pdf

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1、GuidanceforIndustryBioequivalenceStudieswithPharmacokineticEndpointsforDrugsSubmittedUnderanANDADRAFTGUIDANCEThisguidancedocumentisbeingdistributedforcommentpurposesonly.Commentsandsuggestionsregardingthisdraftdocumentshouldbesubmittedwithin90daysofpublicationintheFederalRegisteroft

2、henoticeannouncingtheavailabilityofthedraftguidance.SubmitcommentstotheDivisionofDocketsManagement(HFA-305),FoodandDrugAdministration,5630FishersLane,rm.1061,Rockville,MD20852.AllcommentsshouldbeidentifiedwiththedocketnumberlistedinthenoticeofavailabilitythatpublishesintheFederalReg

3、ister.Forquestionsregardingthisdraftdocument,contactDianaSolana-Sodeindeat240-402-3908.U.S.DepartmentofHealthandHumanServicesFoodandDrugAdministrationCenterforDrugEvaluationandResearch(CDER)December2013BiopharmaceuticsGuidanceforIndustryBioequivalenceStudieswithPharmacokineticEndpoi

4、ntsforDrugsSubmittedUnderanANDAAdditionalcopiesareavailablefrom:OfficeofCommunicationDivisionofDrugInformation,WO51,Room2201CenterforDrugEvaluationandResearchFoodandDrugAdministration10903NewHampshireAve.SilverSpring,MD20993-0002Phone:301-796-3400;Fax:301-847-8715druginfo@fda.hhs.go

5、vhttp://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/default.htm.U.S.DepartmentofHealthandHumanServicesFoodandDrugAdministrationCenterforDrugEvaluationandResearch(CDER)December2013BiopharmaceuticsContainsNonbindingRecommendationsDraft–NotforImplementationTABLE

6、OFCONTENTSI.INTRODUCTION.............................................................................................................1II.BACKGROUND...............................................................................................................2III.ESTABLISHINGBIOEQUIV

7、ALENCE........................................................................2A.PharmacokineticStudies...............................................................................................................31.GeneralConsiderations.............................................

8、...................