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1、StabilityStudiesforDrugRegistrationsAAPS/CPACMCWorkshop:Quality,RegulatoryandScientificRequirementsandStrategiesShanghai,June2010StephenT.Colgan,Ph.D.PfizerGlobalResearchandDevelopment0謝謝你的邀請在此化學質量控制研討會發(fā)言這是我第一次訪問中國我非常高興能在這里！PfizerGlobalResearchandDevelo
2、pmentPfizer?InternalUse1ConceptsthatwillbediscussedInclude…..ConceptsthatwillbediscussedInclude…..￠TheScientificandRegulatoryObjectivesforStabilityStudies–SpecificIssuesrelatedtoAPIandDPStabilityPrograms￠CurrentRegulatoryGuidanceonStability–(FocusonRegi
3、strationStability)￠StabilityDesignOptions–BracketingandMatrixingStrategies–OtherScience-basedTestingProtocols￠StabilityStudiesforClinicalTrials/MarketingApplications/GenericsandLineExtensionsPfizerGlobalResearchandDevelopmentPfizer?InternalUse2Conceptst
4、hatwillbediscussedInclude…..ConceptsthatwillbediscussedInclude…..￠AppropriateuseofExtrapolationtoset–ClinicalUse-PeriodsandCommercialShelfLifeforDrugProduct–Re-testperiodsforDrugSubstance￠Stability-RelatedRegulatoryQueries￠EmergingStabilityIssues￠Stabil
5、ity-RelatedResourcesPfizerGlobalResearchandDevelopmentPfizer?InternalUse3TakeHomeMessagesTakeHomeMessages￠StabilityStudiesareconductedformanyreasons–TosupportClinicalTrials/MarketingApplications/PostapprovalChanges–Todetermineexpiryorretestdates–AsaTool
6、forProductDevelopmentandProductUnderstanding–ToConfirmQualitybetweenBatches￠TheScientificandRegulatoryObjectivesforStabilityaregenerallyalignedGlobally,butRegulatorsfromdifferentregionshavedifferentexpectations￠Stabilityqueriesindicateaperceivedlackofst
7、abilityunderstandingbytheapplicant￠TherearealternativewaysforIndustrytomeetitsStabilityCommitmentsPfizerGlobalResearchandDevelopmentPfizer?InternalUse4TheScientificandRegulatoryObjectivesforTheScientificandRegulatoryObjectivesforStabilityStudiesStabilit
8、yStudies￠ForClinicalApplications￠StabilityStudiesareprosecutedtoconfirmthattheinvestigationdrugproductmeetsallproposedspecificationrequirementsthroughouttheuseperiod/clinicaltrial(EMA,FDA)–Toprotectthepatient?Impuritiesmayhavesaf
