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当前位置:首页 > 行业资料 > 技术标准资料 > 国家标准 > USP体内生物等效性试验指南GuidanceSelectionComparatorPharmaceuticalProductsEquivalenceAssessmentInterchang

USP体内生物等效性试验指南GuidanceSelectionComparatorPharmaceuticalProductsEquivalenceAssessmentInterchang

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  • 2020-11-10 21:47:44
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161©WorldHealthOrganizationWHOTechnicalReportSeries,No.902,2002Annex11Guidanceontheselectionofcomparatorpharmaceuticalproductsforequivalenceassessmentofinterchangeablemultisource(generic)productsIntroductionThisannexprovidesalistofcomparatorproductsforequivalenceassessmentofinterchangeablemultisource(generic)products.TheinformationoncomparatorpharmaceuticalproductswascollectedbytheSecretariatfromdrugregulatoryauthoritiesandpharmaceuticalcompanies.Thelisthasbeendrawnuptoassistregulatoryauthoritiesandpharmaceuticalcompaniesindecidingonappropriatecompara-torproductsinthecontextofmultisource(generic)marketingautho-rization.Theinformationcouldalsobeusedfordrugprocurementpurposes.Wherethecomparatorpharmaceuticalproductisnotclearlydefined,criteriaaresuggestedthatareprovidedinadecision-treeformat(seeFigure1).Thispermitstheselectionofacomparatorpharmaceuticalproduct.Theguidelinesonregistrationrequirementstoestablishinterchange-abilityofmultisource(generic)pharmaceuticalproductspublishedbyWHO(1)

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