上海CMC培训 AAPSCPA CMC Workshop Quality, Regulatory and Scientific Requirements and Strategies

《上海CMC培训 AAPSCPA CMC Workshop Quality, Regulatory and Scientific Requirements and Strategies》由会员上传分享，免费在线阅读，更多相关内容在行业资料-天天文库。

1、StabilityStudiesforDrugRegistrationsAAPS/CPACMCWorkshop:Quality,RegulatoryandScientificRequirementsandStrategiesShanghai,June2010StephenT.Colgan,Ph.D.PfizerGlobalResearchandDevelopment0谢谢你的邀请在此化学质量控制研讨会发言这是我第一次访问中国我非常高兴能在这里！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