报批美国FDA仿制药研发与相关问题探讨-FinalPPT推荐.ppt
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报批美国FDA仿制药研发与相关问题探讨-FinalPPT推荐.ppt
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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?
PharmaceuticalQualitybyDesign(QbD)QbDmeansdesigninganddevelopingQbDmeansdesigninganddevelopingformulationsandmanufacturingprocessestoformulationsandmanufacturingprocessestoensurepredefinedproductqualityensurepredefinedproductqualityUnderstandingandcontrollingformulationandUnderstandingandcontrollingformulationandmanufacturingprocessvariablesaffectingthemanufacturingprocessvariablesaffectingthequalityofadrugproductqualityofadrugproductEssentialelementsofQbDDefinitionofthequalitytargetproductprofileHighlevelqualityaspectsoftheproduct:
purity,drugrelease(dissolution/disintegrationtime),pharmacokineticprofile,etc.Criticalqualityattributes(CQAs)fordrugproductCharacteristicsofDPwhichhaveimpactondesiredprofileConsciousattempttostudyandcontrolCriticalProcessParameters(CPPs)IdentificationofmaterialpropertiesandprocessparameterswhichhaveeffectonproductCQAsDesignSpace:
ThemultidimensionalcombinationandinteractionofinputvariablesandprocessparametersthathavebeendemonstratedtoprovideassuranceofqualityIdentificationofacontrolstrategyforcriticalprocessparametersWhatisQbD?
RawMaterialsEquipmentEnvironmentOperatorsVariableInputsx“Locked”Process=VariableQualityHowDidWeWorkinthePastWhatisQbD?
RawMaterialsEquipmentEnvironmentOperatorsUnderstoodVariableInputsxUnderstoodandControlledProcess=PredefinedQualityFlexibleProcessDesignSpaceHowCanWeWorkintheFutureWhatisQbD?
RawMaterialsWetGranulationFluidBedDryingBlendingCompressionProductDrugSubstanceExcipientsSourceAssayImpuritiesLODPSWhatisQbD?
RawMaterialsWetGranulationFluidBedDryingBlendingCompressionWaterBinderTempSprayRateSpeedTimeP.SWhatisQbD?
RawMaterialsWetGranulationFluidBedDryingBlendingCompressionWhatisQbD?
RawMaterialsWetGranulationFluidBedDryingBlendingCompressionAirFlowTempRHShockCycleP.S.WhatisQbD?
RawMaterialsWetGranulationFluidBedDryingBlendingCompressionFillVolumeRotationSpeedEndPoint(Time)BlendUniformityDensitiesAngleofReposeWhatisQbD?
RawMaterialsWetGranulationFluidBedDryingBlendingCompressionFeedFrameToolingPunchPenetrationDepthCompressionForcePressSpeedFeederSpeedQualityAssessmentunderQbRQuestion-basedReview(QbR)isageneralQuestion-basedReview(QbR)isageneralframeworkforascienceandrisk-basedframeworkforascienceandrisk-basedassessmentofproductqualityassessmentofproductqualityQbRcontainstheimportantscientificandQbRcontainstheimportantscientificandregulatoryreviewquestionstoregulatoryreviewquestionstoComprehensivelyassesscriticalformulationandComprehensivelyassesscriticalformulationandmanufacturingprocessvariablesmanufacturingprocessvariablesSetregulatoryspecificationsrelevanttoqualitySetregulatoryspecificationsrelevanttoqualityDeterminethelevelofriskassociatedwiththeDeterminethelevelofriskassociatedwiththemanufactureanddesignoftheproductmanufactureanddesignoftheproductExamplesofQbDquestionsunderQbRControlofDrugSubstanceWhatisthedrugsubstancespecification?
Doesitincludeallthecriticaldrugsubstanceattributesthataffectthemanufacturingandqualityofthedrugproduct?
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- 报批 美国 FDA 制药 研发 相关 问题 探讨 Final