报批美国FDA仿制药研发与相关问题探讨-Final.ppt

报批美国FDA仿制药研发与相关问题探讨-Final.ppt

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开发报批美国开发报批美国FDA的仿制药的仿制药与相关问题探讨与相关问题探讨上海复星普适医药科技有限公司上海复星普适医药科技有限公司上海复星普适医药科技有限公司上海复星普适医药科技有限公司何平何平何平何平内容提要内容提要开发仿制药的重要性和机遇开发仿制药的挑战申报仿制药的分类仿制药研发团队仿制药的研发过程QbD在制剂开发中怎么体现研发（高难）仿制药的一些体会：

案例研究开发仿制药的重要性新药与仿制药新药与仿制药-NDA-NDAandandANDAANDA开发仿制药与我国药物研发的海外战略开发仿制药与我国药物研发的海外战略药物制剂药物制剂目标主流市场目标主流市场开发仿制药的挑战性开发仿制药更具挑战性药物制剂药物制剂专利专利仿制药的竞争仿制药的竞争仿制药厂之间的竞争仿制药厂之间的竞争由品牌药转成仿制药由品牌药转成仿制药仿制药竞争的方式HOWTOCOMPETECost-IRProductRawMaterialsRawMaterialsProcessProcessFinishedProductFinishedProductTechnology-ModifiedReleaseProducts申报（仿制）新药的分类规范市场规范市场（FDA）1。

P-I2。

P-II3。

P-III4。

P-IV（1（1ststtofile）tofile）中国市场（中国市场（sFDA）11类类类类22类类类类33类类类类44类类类类55类类类类66类类类类仿制药研发团队CONCEPT-1BUILDUPATEAMINFORMATIONFORMULATIONPRODUCTREGULATORYANALYTICALBIO-PHARMACEUTICALPROJECTLEGELDRUGDELIVERYSYSTEMSFORORALSOLIDFORMULATIONS-MRMATRIXSYSTEMSMATRIXSYSTEMSRESERVIORSYSTEMSRESERVIORSYSTEMSOSMOTICALPUMPSYSTEMSOSMOTICALPUMPSYSTEMSCOMBO-SYSTEMSCOMBO-SYSTEMS缓控释给药的技术平台和给药系统CONCEPT-2BUILDUPASYSTEMProductDevelopmentRoadmap仿制药的仿制药的研发过程研发过程QualityAcceptablylowriskoffailingtoachievethedesiredclinicalattributesPharmaceuticalQuality=fdrugsubstance,excipients,manufacturing.QbDProductandprocessperformancecharacteristicsscientificallydesignedtomeetspecificobjectives,notmerelyempiricallyderivedfromperformanceoftestbatchesWhatisQbD（QualitybyDesign）?

QbDQbD在制剂开发中怎么体现？

在制剂开发中怎么体现？

WhatisQbD?

QbDQbD在制剂开发中怎么体现？

在制剂开发中怎么体现？

PharmaceuticalQualitybyDesign（QbD）QbDmeansdesigninganddevelopingQbDmeansdesigninganddevelopingformulationsandmanufacturingprocessestoformulationsandmanufacturingprocessestoensurepredefinedproductqualityensurepredefinedproductqualityUnderstandingandcontrollingformulationandUnderstandingandcontrollingformulationandmanufacturingprocessvariablesaffectingthemanufacturingprocessvariablesaffectingthequalityofadrugproductqualityofadrugproductEssentialelementsofQbDDefinitionofthequalitytargetproductprofileHighlevelqualityaspectsoftheproduct:

purity,drugrelease（dissolution/disintegrationtime）,pharmacokineticprofile,etc.Criticalqualityattributes（CQAs）fordrugproductCharacteristicsofDPwhichhaveimpactondesiredprofileConsciousattempttostudyandcontrolCriticalProcessParameters（CPPs）IdentificationofmaterialpropertiesandprocessparameterswhichhaveeffectonproductCQAsDesignSpace:

ThemultidimensionalcombinationandinteractionofinputvariablesandprocessparametersthathavebeendemonstratedtoprovideassuranceofqualityIdentificationofacontrolstrategyforcriticalprocessparametersWhatisQbD?

QbDQbD在制剂开发中怎么体现？

在制剂开发中怎么体现？

RawMaterialsEquipmentEnvironmentOperatorsVariableInputsx“Locked”Process=VariableQualityHowDidWeWorkinthePastWhatisQbD?

QbDQbD在制剂开发中怎么体现？

在制剂开发中怎么体现？

RawMaterialsEquipmentEnvironmentOperatorsUnderstoodVariableInputsxUnderstoodandControlledProcess=PredefinedQualityFlexibleProcessDesignSpaceHowCanWeWorkintheFutureWhatisQbD?

QbDQbD在制剂开发中怎么体现？

在制剂开发中怎么体现？

WhatisQbD?

QbDQbD在制剂开发中怎么体现？

在制剂开发中怎么体现？

RawMaterialsWetGranulationFluidBedDryingBlendingCompressionProductDrugSubstanceExcipientsSourceAssayImpuritiesLODPSWhatisQbD?

QbDQbD在制剂开发中怎么体现？

在制剂开发中怎么体现？

RawMaterialsWetGranulationFluidBedDryingBlendingCompressionWaterBinderTempSprayRateSpeedTimeP.SWhatisQbD?

QbDQbD在制剂开发中怎么体现？

在制剂开发中怎么体现？

RawMaterialsWetGranulationFluidBedDryingBlendingCompressionWhatisQbD?

QbDQbD在制剂开发中怎么体现？

在制剂开发中怎么体现？

RawMaterialsWetGranulationFluidBedDryingBlendingCompressionAirFlowTempRHShockCycleP.S.WhatisQbD?

QbDQbD在制剂开发中怎么体现？

在制剂开发中怎么体现？

RawMaterialsWetGranulationFluidBedDryingBlendingCompressionFillVolumeRotationSpeedEndPoint（Time）BlendUniformityDensitiesAngleofReposeWhatisQbD?

QbDQbD在制剂开发中怎么体现？

在制剂开发中怎么体现？

RawMaterialsWetGranulationFluidBedDryingBlendingCompressionFeedFrameToolingPunchPenetrationDepthCompressionForcePressSpeedFeederSpeedQualityAssessmentunderQbRQuestion-basedReview（QbR）isageneralQuestion-basedReview（QbR）isageneralframeworkforascienceandrisk-basedframeworkforascienceandrisk-basedassessmentofproductqualityassessmentofproductqualityQbRcontainstheimportantscientificandQbRcontainstheimportantscientificandregulatoryreviewquestionstoregulatoryreviewquestionstoComprehensivelyassesscriticalformulationandComprehensivelyassesscriticalformulationandmanufacturingprocessvariablesmanufacturingprocessvariablesSetregulatoryspecificationsrelevanttoqualitySetregulatoryspecificationsrelevanttoqualityDeterminethelevelofriskassociatedwiththeDeterminethelevelofriskassociatedwiththemanufactureanddesignoftheproductmanufactureanddesignoftheproductExamplesofQbDquestionsunderQbRControlofDrugSubstanceWhatisthedrugsubstancespecification?

Doesitincludeallthecriticaldrugsubstanceattributesthataffectthemanufacturingandqualityofthedrugproduct?

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