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2023/10/101BridgingStudies-AGenomicApproachatThe34TrainingCourseonClinicalTrialsFoundationofMedicalProfessionalsAllianceinTaiwanOctober14,2023TheviewsexpressedinthispaperareprofessionalopinionsofthepresenterandmaynotnecessarilyrepresentthepositionoftheNationalTaiwanUniversityandNationalHealthResearchInstitutes,Taiwan.
2023/10/102AcknowledgementsandThanks?Herng-DerChen,MD,PhD,CenterforDrugEvaluation?MeyWang,PhD,CenterforDrugEvaluation?Chin-FuHsiao,PhD,NationalHealthResearchInstitutes
2023/10/103OutlineI.StatisticalInterpretationofICHE5II.ImplementationofBridgingStudiesIII.ExamplesofBridgingStudiesIV.CurrentStatisticalApproachesV.AStatisticalGenomicApproachVI.Summary
2023/10/104StatisticalInterpretationofICHE5ICHE5ICHHarmonisedTripartiteGuideline(Feb.5,1998)EthnicFactorsintheAcceptabilityofForeignClinicalDataAUSFDAGuidance(FederalRegister,June10,1998)
2023/10/105StatisticalInterpretationofICHE5ICHE5EthnicFactorsintheAcceptabilityofForeignClinicalDataThepurposeofthisguidanceistofacilitatetheregistrationofmedicinesamongICHregionsbyrecommendingaframeworkforevaluatingtheimpactofethnicfactorsuponamedicine’seffect,i.e.,itsefficacyandsafetyataparticulardosageanddoseregimen.
2023/10/106StatisticalInterpretationofICHE5ObjectivesofICHE5(Section1.1)Todescribethecharacteristicsofforeignclinicaldatathatwillfacilitatetheirextrapolationtodifferentpopulationandsupporttheiracceptanceasabasisforregistrationofamedicineinanewregion.Todescriberegulatorystrategiesthatminimizeduplicationofclinicaldataandfacilitateacceptanceofforeignclinicaldatainthenewregion. Todescribetheuseofbridgingstudy,whennecessary,toallowextrapolationofforeignclinicaldatatoanewregion.Todescribedevelopmentstrategiescapableofcharacterizingethn
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