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I:\\16645dftR1.doc4/20/16AssayDevelopmentandValidationforImmunogenicityTestingofTherapeuticProteinProductsGuidanceforIndustryDRAFTGUIDANCEThisguidancedocumentisbeingdistributedforcommentpurposesonly.Commentsandsuggestionsregardingthisdraftdocumentshouldbesubmittedwithin60daysofpublicationintheFederalRegisterofthenoticeannouncingtheavailabilityofthedraftguidance.Submitelectroniccommentsto(HFA-305),FoodandDrugAdministration,5630FishersLane,rm.1061,Rockville,MD20852.AllcommentsshouldbeidentifiedwiththedocketnumberlistedinthenoticeofavailabilitythatpublishesintheFederalRegister.Forquestionsregardingthisdraftdocument,contact(CDER)SusanKirshnerat301-827-1731;(CBER)OfficeofCommunication,OutreachandDevelopment,800-835-4709or240-402-8010;or(CDRH)OfficeofCommunicationandEducation,800-638-2041or301-796-7100.U.S.DepartmentofHealthandHumanServicesFoodandDrugAdministrationCenterforDrugEvaluationandResearch(CDER)CenterforBiologicsEvaluationandResearch(CBER)CenterforDevicesandRadiologicalHealth(CDRH)April2016PharmaceuticalQuality/CMCRevision1AssayDevelopmentandValidationforImmunogenicityTestingofTherapeuticProteinProductsGuidanceforIndustryAdditionalcopiesareavailablefrom:OfficeofCommunications,DivisionofDrugInformationCenterforDrugEvaluationandResearchFoodandDrugAdministration10001NewHampshireAve.,HillandaleBldg.,4thFloorSilverSpring,MD20993-0002Phone:855-543-3784or301-796-3400;Fax:301-431-6353Email:druginfo@fda.hhs.gov:800-835-4709or240-402-8010Email:ocod@fda.hhs.gov:800-638-2041or301-796-7100;Fax:301-847-8149Email:DICE@fda.hhs.gov(CDER)CenterforBiologicsEvaluationandResearch(CBER)CenterforDevicesandRadiologicalHealth(CDRH)April2016PharmaceuticalQuality/CMCRevision1ContainsNonbindingRecommendationsDraft—NotforImplementationTABLEOFCONTENTSI.INTRODUCTION.............................................................................................................1II.BACKGROUND...............................................................................................................2III.GENERALPRINCIPLES................................................................................................2IV.ASSAYDESIGNELEMENTS........................................................................................4A.TestingStrategy.............................................................................................................................41.Multi-TieredTestingApproach........................................................................................................42.ImmunoglobulinIsotypes.................................................................................................................53.EpitopeSpecificity...........................................................................................................................5B.AssayCutPoint..............................................................................................................................6C.Sensitivity........................................................................................................................................71.AssaySensitivity...............................................................................................................................72.DrugTolerance................................................................................................................................8D.SpecificityandSelectivity..............................................................................................................81.MatrixInterference..........................................................................................................................92.MinimalRequiredDilution............................................................................................................10E.Precision........................................................................................................................................10F.Reproducibility.............................................................................................................................11G.RobustnessandSampleStability.....................................
本文标题:Validation for Immunogenicity Testing of Therapeut
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