2-3a_Pharmaceutical Development_ China

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1、DossierRequirementsforGenericMedicineQuality(PartII)PharmaceuticalDevelopmentSultanGhaniFocusofPresentation•PharmaceuticalDevelopment•ApplicationRequirementsPHARMACEUTICALDEVELOPMENTCompanyResearchandDevelopment•Developessentiallysimilarformulationtotheinnovatorproduct•

2、Minimizetheriskrelatedtocompatibility,manufacturability,stabilityandbioavailability•Forfixed-dosecombination,FPPtakeintoaccounttheformulaofindividualcomponentsofcomparatorFPPsPHARMACEUTICALDEVELOPMENTDevelopmentStrategy•Product-specificanalyticalmethods–Validationofmeth

3、ods–AcceptablerangeofCQAsandCPPs–Dissolutionmethodthatdiscriminatesanddetectschangesbetweenformulations,and–Sensitivetochangesinmanufacturingprocess•Characterizationofcomparatorproduct(s)–Comparativeanalysisofallattributes(pharmaceuticalequivalence)–Potentiallycriticala

4、ttributesofprimarypackagingmaterial(s)–RationaleandjustificationofscorelineontabletPHARMACEUTICALDEVELOPMENTAstepwiseapproachistakeninthedevelopmentwork•Pre-formulationstudies•Formulationdevelopmentandprocessoptimization•Scale-upofmanufacturingprocessconsideration•Proce

5、ssvalidation•Processtechnologytransfer•DocumentationPHARMACEUTICALDEVELOPMENTPre-formulationstudies•Drugandexcipientpropertiesarecriticaltothemanufacturingprocessandscale-upofsoliddosageform.Theyare:–Particleshape,sizeandsurfacearea–Solvabilityinwaterorgranulatingfluid–

6、Crystallinityandpolymorphism–Moisturesensitivity–Bulkandtappeddensities–Flowparameters–Granulatingproperties–Dryingproperties–CompactionbehaviourPHARMACEUTICALDEVELOPMENTDifferingapproachofPharmaceuticalDevelopment(Summary)AspectMinimalApproachesEnhancedApproachesPharma

7、ceuticalEmpiricalapproachQualitybyDesign(QbD)DevelopmentManufacturingFixedAdjustablewithDesignspaceprocessProcesscontrolIn-processtestPATtoolsProductBasedonbatchdataBasedonproductSpecificationperformanceControlQualitycontrolledbyin-Qualitycontrolledbyriskstrategyprocess

8、andendproductbasedapproachwithrealtimetestingreleasetestingLifecycleReactivePreventivemanagement7PHARMACEUTICA