开发报批美国FDA的仿制(fǎngzhì)药与相关问题探讨上海复星普适医药(yīyào)科技有限公司何平第一页，共四十一页。内容提要(nèirónɡtíyào)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(ɡāo)nán)仿制药的一些体会：案例研究第二页，共四十一页。开发(kāifā)仿制药的重要性新药与仿制(fǎngzhì)药-NDAandANDA••开发仿制药与我国药物研发的海外战略药物制剂目标(mùbiāo)主流市场第三页，共四十一页。开发(kāifā)仿制药的挑战性开发仿制药更具挑战性药物制剂专利仿制药的竞争(jìngzhēng)•仿制药厂之间的竞争•由品牌药转成仿制药第四页，共四十一页。仿制(fǎngzhì)药竞争的方式HOWTOCOMPETECost-IRProduct•RawMaterials–Process––FinishedProduct•Technology-ModifiedReleaseProducts第五页，共四十一页。申报(仿制)(fǎngzhì)新药的分类规范市场(FDA)中国(zhōnɡɡuó)市场（sFDA）1。P-I2。P-II1类3。P-III2类4。P-IV(1sttofile)3类4类5类6类第六页，共四十一页。仿制(fǎngzhì)药研发团队CONCEPT-1BUILDUPATEAMINFORMATIONBIO-PHARMACEUTICALPROJECTPRODUCTFORMULATIONREGULATORYLEGELANALYTICAL第七页，共四十一页。缓控释给药的技术(jìshù)平台和给药系统CONCEPT-2BUILDUPASYSTEMDRUGDELIVERYSYSTEMSFORORALSOLIDFORMULATIONS-MR•–MATRIXSYSTEMSRESERVIORSYSTEMS–OSMOTICALPUMPSYSTEMS––COMBO-SYSTEMS第八页，共四十一页。ProductDevelopmentRoadmap仿制(fǎngzhì)药的研发过程第九页，共四十一页。WhatisQbD(QualitybyDesign)?QbD在制剂(zhìjì)开发中怎么体现？•Quality–Acceptablylowriskoffailingtoachievethedesiredclinicalattributes•PharmaceuticalQuality=f{drugsubstance,excipients,manufacturing..}•QbD–‘Productandprocessperformancecharacteristicsscientificallydesignedtomeetspecificobjectives,notmerelyempiricallyderivedfromperformanceoftestbatches’第十页，共四十一页。WhatisQbD?QbD在制剂开发(kāifā)中怎么体现？•PharmaceuticalQualitybyDesign(QbD)–QbDmeansdesigninganddevelopingformulationsandmanufacturingprocessestoensurepredefinedproductquality•Understandingandcontrollingformulationandmanufacturingprocessvariablesaffectingthequalityofadrugproduct第十一页，共四十一页。WhatisQbD?QbD在制剂开发中怎么(zěnme)体现？EssentialelementsofQbDDefinitionofthequalitytargetproductprofileHighlevelqualityaspectsoftheproduct:purity,drugrelease(dissolution/disintegrationtime),pharmacokineticprofile,etc.Criticalqualityattributes(CQAs)fordrugproduct•CharacteristicsofDPwhichhaveimpactondesiredprofile•ConsciousattempttostudyandcontrolCriticalProcessParameters(CPPs)•IdentificationofmaterialpropertiesandprocessparameterswhichhaveeffectonproductCQAsDesignSpace:ThemultidimensionalcombinationandinteractionofinputvariablesandprocessparametersthathavebeendemonstratedtoprovideassuranceofqualityIdentificationofacontrolstrategyforcriti第ca十l二p页，ro共四ce十s一s页。parametersWhatisQbD?QbD在制剂(zhìjì)开发中怎么体现？HowDidWeWorkinthePastVariableInputsx“Locked”Process=VariableQualityRawMaterialsEquipmentEnvironmentOperators第十三页，共四十一页。WhatisQbD?QbD在制剂开发(kāifā)中怎么体现？HowCanWeWorkintheFutureUnderstoodUnderstoodand=PredefinedQualityVariableInputsxControlledProcessRawMaterialsEquipmentEnvironmentOperatorsFlexibleProcessDesignSpace第十四页，共四十一页。WhatisQbD?QbD在制剂开发中怎么(zěnme)体现？RawMaterialsWetFluidBedBlendingCompressionProductGranulationDrying第十五页，共四十一页。WhatisQbD?QbD在制剂开发(kāifā)中怎么体现？RawWetFluidBedBlendingC...
