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小水媛媛
2011-04-16 0人阅读 举报 0 0 暂无简介

简介:本文档为《4pdf》,可适用于工程科技领域

ORALDOSAGEFORMVolumeDRUGDEVELOPMENTSERIESVOLUMEDRUGDEVELOPMENTSERIESPRODUCTDEVELOPMENTImmediateReleaseHANDBOOKOFPHARMACEUTICALGENERICDEVELOPMENTORALTabletsVOLUMEIPartONEDrugDevelopmentSolidOralDosageFormsGENERICDEVELOPMENTHandbookofPharmaceuticalGenericDevelopmentSeriesORALDOSAGEFORMVolumeDRUGDEVELOPMENTSERIESVOLUMEDRUGDEVELOPMENTSERIESPRODUCTDEVELOPMENTSERIALNUMBERDONOREMOVE!REGISTEREDWITHLOCUMINTERNATIONALPUBLISHERSREGISTRATIONSERVICESWARNING:THISISSUEAISMULTIPLEPAGEUVENCODEDEDITIONHPGDVolSERIESORALTABLETSPartIFirstInternationalEditionFirstpublishedanddistributedinUK,US,EU,RSA,IsraelandJapaninNovember:byLocumInternationalPublishingHouse(Houston,Israel,SouthAfrica)SecondInternationalEdition(FirsttoFourthPrint)FourthprintingpublishedanddistributedinUK,US,EU,Israel,Asia,andJapaninJanuarybyLocumInternationalPublishingHouse(Houston,Israel,SouthAfrica)inHardCoverSoftandSpiralCoverElectronicDisketteandemailattachmentversionsAllprintandelectronicversionsidenticalincontentandformatCopyright©,HandbookofPharmaceuticalGenericDevelopmentTextCopyright©,HandbookofPharmaceuticalGenericDevelopmentIllustrationcopyright©,HandbookofPharmaceuticalGenericDevelopmentLocumInternationalPublishingHousePOBox,GiladStreetKochavYairIsraelAllrightreservedISSNISSNElectronicVersion(Diskette,CDROMandemailattachmentversion)HandbookDevelopmentvolumeseriesGeneralGenericDevelopmentISSNSeriesnumberGeneralGenericDevelopmentISSNSeriesnumberElectronicIssue(Disketteandemailattachmentversionareidenticalinsizeandcontenttotheprintedhardorsoftcoverversion)Duplication:Nopartofthispublicationmaybereproduced,storedinaretrievalsystemortransmittedinanyformorbyanymeans,electronic,mechanical,photocopying,microfilming,recordingorotherwise,withoutthepriorwrittenpermissionofthecopyrightownerorsubjecttothefollowingconditions:Authorizationtophotocopyitemsforinternalorpersonaluseorinternalorpersonaluseofspecificcompanypersonnel,isgrantedbyLocumInternationalPublishingHouse,providedthatthebasefeeof$perpageispaiddirectlytotheCopyrightClearanceCenter(CCC)RosewoodDrive,Danvers,MAUSAFororganizationsthathavebeengrantedaphotocopylicensebyCCC,aseparatesystemofpaymenthasbeenarrangedForadditionalinformation,contactthePublicationsDepartmentLocumInternationalPublishingHousePOBox,GiladStreet,KochavYair,IsraelUKFax:()USFax:()Fax:Email:infolocumcoilhttp:wwwlocumcoilhttp:wwwlocumeurocomhttp:wwwlocumusacomhandbookslocumusacomCurrentPrinting(lastdigit):saleslocumusacomÖPRINTEDINUSAPRINTEDINISRAELPRINTEDINIRELANDPRINTEDINREPUBLICOFSOUTHAFRICAORALDOSAGEFORMVolumeDRUGDEVELOPMENTSERIESVOLUMEDRUGDEVELOPMENTSERIESPRODUCTDEVELOPMENTPartOneOneOORALTABLETSImmediateReleaseDrugDevelopmentLocumInternationalPublishersHandbookofPharmaceuticalGenericDevelopmentCopyright©LocumPublishingHouseIncAllRightsReservedNeitherthisbooknoranypartmaybereproducedortransmittedinanyformorbyanymeans,electronicormechanical,includingphotocopying,microfilmingandrecording,orbyanyinformationstorageandretrievalsystem,withoutthepermissionofthepublishersORALDOSAGEFORMVolumeDRUGDEVELOPMENTSERIESVOLUMEDRUGDEVELOPMENTSERIESPRODUCTDEVELOPMENTTheCompleteHandbookSeriesofPharmaceuticalDrugDevelopmentISBNElectronicVersionHandbookDevelopmentVolumeSeriesISSNSeriesNumberXElectronicVersionHandbookofPharmaceuticalGenericDevelopmentPartI(Development)PartII(DevelopmentANDAorEUDossier)VolTabletsOralHandbookofPharmaceuticalGenericDevelopmentPartI(Development)PartII(DevelopmentANDAorEUDossier)VolCapsulesOralHandbookofPharmaceuticalGenericDevelopmentPartI(Development)PartII(DevelopmentANDAorEUDossier)VolSemisolidsHandbookofPharmaceuticalGenericDevelopmentPartI(Development)PartII(DevelopmentANDAorEUDossier)VolLiquidsOralHandbookofPharmaceuticalGenericDevelopmentPartI(Development)PartII(DevelopmentANDAorEUDossier)VolSGCapsulesHandbookofPharmaceuticalGenericDevelopmentVoleSOPsSOPsHandbookofPharmaceuticalGenericDevelopmentPartI(Development)PartII(DevelopmentANDAorEUDossier)VolSuspensionsHandbookofPharmaceuticalGenericDevelopmentPartI(Development)PartII(DevelopmentANDAorEUDossier)VolEyeNoseHandbookofPharmaceuticalGenericDevelopmentPartI(Development)PartII(DevelopmentANDAorEUDossier)VolAerosolsMDIHandbookofPharmaceuticalGenericDevelopmentPartI(Development)PartII(DevelopmentANDAorEUDossier)VolTabletsCRMRHandbookofPharmaceuticalGenericDevelopmentPartI(Development)PartII(DevelopmentANDAorEUDossier)VolCapsulesERHandbookofPharmaceuticalGenericDevelopmentPartI(Development)PartII(DevelopmentANDAorEUDossier)VolTabletsOralDRHandbookofPharmaceuticalGenericDevelopmentPartI(MethodValidation)PartII(AnalyticalMethods)VolAnalytical(TopGenericAssayMethods)HandbookofPharmaceuticalInnovativeDevelopmentVolTabletsOralHandbookofPharmaceuticalInnovativeDevelopmentVolCapsulesOralHandbookofPharmaceuticalInnovativeDevelopmentVolSuspensionsOralHandbookofPharmaceuticalDrugDevelopment(MasterFormulaManufacturingInstructionsParts)VolMFandMMIHandbookofPharmaceuticalDrugDevelopment(MasterFormulaManufacturingInstructionsParts)VolMFandMMIHandbookofPharmaceuticalInnovativeDevelopmentPartI,IIIII(Development,ManufacturingEngineering)VolSOPsPAIChecklistHandbookofPharmaceuticalDrugDevelopmentPartI(Development)PartII(DevelopmentANDAorEUDossier)VolSterileInjectionsAvailableasPrint,Online,CDROMorelectronicmailattachmentAdditionalDrugSpecificVolumesinPreparationAnongoingelectronicandprintseriesAvailableeitherasHardBound,SoftBoundorSoftSpiralCover(forUpdating)ForDrugSpecificHandbooksrefertotheDrugDevelopmentSeriestitledREADYTOGO™DRUGDEVELOPMENTSERIEShttp:wwwlocumusacomgopphttp:wwwiagimorgppORALDOSAGEFORMVolumeDRUGDEVELOPMENTSERIESVOLUMEDRUGDEVELOPMENTSERIESPRODUCTDEVELOPMENTSERIALNUMBERDONOREMOVE!REGISTEREDWITHLOCUMINTERNATIONALPUBLISHERSREGISTRATIONSERVICESWARNING:THISISSUEAISMULTIPLEPAGEUVENCODEDEDITIONHPGDVolSERIESORALTABLETSPartIFirstInternationalEditionFirstpublishedanddistributedinUK,US,EU,RSA,IsraelandJapaninNovember:byLocumInternationalPublishingHouse(Houston,Israel,SouthAfrica)SecondInternationalEdition(FirsttoFourthPrint)FourthprintingpublishedanddistributedinUK,US,EU,Israel,Asia,andJapaninJanuarybyLocumInternationalPublishingHouse(Houston,Israel,SouthAfrica)inHardCoverSoftandSpiralCoverElectronicDisketteandemailattachmentversionsAllprintandelectronicversionsidenticalincontentandformatCopyright©,HandbookofPharmaceuticalGenericDevelopmentTextCopyright©,HandbookofPharmaceuticalGenericDevelopmentIllustrationcopyright©,HandbookofPharmaceuticalGenericDevelopmentLocumInternationalPublishingHousePOBox,GiladStreetKochavYairIsraelAllrightreservedISSNISSNElectronicVersion(Diskette,CDROMandemailattachmentversion)HandbookDevelopmentvolumeseriesGeneralGenericDevelopmentISSNSeriesnumberGeneralGenericDevelopmentISSNSeriesnumberElectronicIssue(Disketteandemailattachmentversionareidenticalinsizeandcontenttotheprintedhardorsoftcoverversion)Duplication:Nopartofthispublicationmaybereproduced,storedinaretrievalsystemortransmittedinanyformorbyanymeans,electronic,mechanical,photocopying,microfilming,recordingorotherwise,withoutthepriorwrittenpermissionofthecopyrightownerorsubjecttothefollowingconditions:Authorizationtophotocopyitemsforinternalorpersonaluseorinternalorpersonaluseofspecificcompanypersonnel,isgrantedbyLocumInternationalPublishingHouse,providedthatthebasefeeof$perpageispaiddirectlytotheCopyrightClearanceCenter(CCC)RosewoodDrive,Danvers,MAUSAFororganizationsthathavebeengrantedaphotocopylicensebyCCC,aseparatesystemofpaymenthasbeenarrangedForadditionalinformation,contactthePublicationsDepartmentLocumInternationalPublishingHousePOBox,GiladStreet,KochavYair,IsraelUKFax:()USFax:()Fax:Email:infolocumcoilhttp:wwwlocumcoilhttp:wwwlocumeurocomhttp:wwwlocumusacomhandbookslocumusacomCurrentPrinting(lastdigit):saleslocumusacomÖPRINTEDINUSAPRINTEDINISRAELPRINTEDINIRELANDPRINTEDINREPUBLICOFSOUTHAFRICAORALDOSAGEFORMVolumeDRUGDEVELOPMENTSERIESVOLUMEDRUGDEVELOPMENTSERIESPRODUCTDEVELOPMENTAcknowledgmentsIAGIM(RD)FoundationIAGIMMembers()ContributionsGenericResearchFirmsAssociateUniversities,TechniconsandConsultantsHandbookSeriesCoordinatingCommitteeInternationalJournalofDrugDevelopmentJournalofPharmaceuticalDevelopmentInternationalJournalofGenericDrugsIAGIMDrugDevelopmentArchivesLocumInternationalArchivesFDAOGDCDERMarylandGuidesandGuidelinesLibraryofCongressAICConferencesEditorialBoardPharmEurUSPNFUSPCBP°ToDoribelleforheryearsofsupportandhelptoSeanforhisexpertknowledgeoncomputerizationtoDavidandAriforrunningtheproject'scomputersandlastlytoPatforhisinestimablecontributionVolumeSeriesHandbookofGenericdevelopmentThirdInternationalEditionLOCUMPUBLISHINGHOUSEÍ°ÎÏÐÍ°ÎORALDOSAGEFORMVolumeDRUGDEVELOPMENTSERIESVOLUMEDRUGDEVELOPMENTSERIESPRODUCTDEVELOPMENTINTRODUCTIONHandbookofGenericDevelopmentOralTabletDosageFormThishandbookisthethirdinternationaleditionoftheongoingvolumeseriesunderthecumulativetitleofHandbookofGenericDrugDevelopmentItisahandson,technicalpresentationthatportraysthecurrentdrugrequirementstepsnecessaryatthetimeofgoingtoprint,oftheAbbreviatedNewDrugApplicationfororaltabletdosageform,namelytabletsandcapletsItiswritteninconjunctionwithPartTwooftheHandbookwhichmodelsasarepresentativeANDAandasanexampleofthedrugdevelopmentprocessrequiredforsolidoraldosageformsTheHandbookisavailableinelectronicformat(CDROM)andeformat(online)TheHandbookisupdatedtocurrentregulatoryrequirementsonceoroccasionallyunderexceptionalcircumstancestwiceannuallyCompleteupdatesareavailablewithoutchargetoAssociationMembersoftheDrugDevelopmentAssociationIAGIMThishandbookprovidesaprovenpathwaytosolidoraldosageformdevelopmentModerncommercialformulationshighlightthecommontabletcapletdevelopmentroutesnamelytheclassicalwetgranulation,spraygranulation,drygranulationandfinallyslugginganddirectcompressionLowactivedosage(<mg)andhighpotency(>)examplesarespeciallychosentodemonstratetheformulationstepsandprocessstagesasaprerequisitetodevelopingstable,elegantandruggedformulasThisHandbookeditionincludesadditionaldataonanalyticalmethodvalidationhasbeenredesignedtomeettheGuidanceforIndustryOrganizationofanAbbreviatedNewDrugApplicationandanAbbreviatedAntibioticApplicationaswellasallFDAguidelineandrequirementsoftheCenterofDrugEvaluationandResearch(CDER)todateofpublishingEditorinChiefISSNAnongoingseriesAdditionalVolumesinPreparationGeneralDrugDevelopmentSeriesISSNElectronicDrugDevelopmentSeriesISSNXӚΩCOPYRIGHTpϛÐpORALTABLETSORALTABLETSTableofContentsHANDBOOKOFGENERICDRUGDEVELOPMENTVIIVOLUMEHANDBOOKSERIESContentsPHARMACEUTICALDEVELOPMENTTableofContentsVIIAcronymsAbbreviationsXIIIIntroductionXIVPrefaceXVForwardXVIChapterRegulatoryPreformulationchecklistDocumentationSOPControlchecklistDevelopmentNotebooksDevelopmentNotebookschecklistSOPControlandDevelopmentNotebooksSOPsChapterDevelopingtheFormulaanOverviewFormulationchecklistDevelopmentformulationsDrugDevelopmentChecklistDevelopmentFormulaSOPsDevelopingtheFormulaProductDevelopmentFlowChartProductDevelopmentGuideDirectCompressionTabletDevelopmentDirectCompressionFlowChartsDirectCompressionMasterFormulaWetGranulationDevelopmentWetDirectCompressionFlowChartsWetGranulationManufacturingFlowChartsWetGranulationMasterFormula(aqueousgranulation)WetGranulationMasterFormula(alcoholicgranulation)ORALTABLETSORALTABLETSTableofContentsHANDBOOKOFGENERICDRUGDEVELOPMENTVIIIVOLUMEHANDBOOKSERIESContentsChapterPurifiedWateranessentialingredientDoandDon'tsinDevelopmentPurifiedWaterChecklistChapterActiveIngredientsDo’sandDon’tsActivechecklistApprovedSuppliersChecklistStandardOperatingProcedures,ActivesChapterSemiactiveingredientsValidatingtheSemiactiveingredients,ChecklistQualifyingtheAntioxidantAntioxidantTabulationsChapterNonactivematerials(excipients)ChecklistnonactiveingredientStandardOperatingProcedures,NonactivesChapterContainerclosuresystemsContainerlinerclosuresystems,ChecklistContainerlinerclosuresystems,SOPsPackagingComponentsPackagingComponentsDocumentationRequirementsSOPPackagingCharacteristicsPackagingComponentDescriptionsPackagingComponentChapterManufacturingInstructionsManufacturingInstructionsChecklistThemanufacturingInstructionsandControlsManufacturingFlowChartsLargescalemanufacturingInstructionsLargescaleMasterFormulaLargescaleManufacturingInstructionsORALTABLETSORALTABLETSTableofContentsHANDBOOKOFGENERICDRUGDEVELOPMENTIXVOLUMEHANDBOOKSERIESContentsChapterInprocessQualityControlsManufacturinginprocesscontrolsChecklistInprocessSpecificationsProcessyieldsInprocessControlSpecificationsInprocessFilmCoatingSpecificationsChapterFinishedProductSpecificationsFinishedProductSpecificationsTabletCapletsFinishedProductSpecificationsChecklistsFinishedProductSpecificationsRequiredSOPsChapterProcessOptimizationandProceduresQualificationofAntioxidantandLubricantQualificationofLossonDryingLimitsChapterScaleupProceduresScaleupprocedureschecklistScaleupproceduresAqueousFilmCoatingChapterCleaningLimitsCleaningLimitsProceduresChecklistCleaningValidationRequirementsSOPsChapterAnalyticalValidationRequirementsAnalyticalTestingOutofSpecificationAnalyticalTestingDo'sandDon'tsRetestingRulesOutofSpecificationsChecklistsRuggednessandRobustnessImpuritiesinDrugSubstancesImpuritiesDo'sandDon'tsImpuritiesGlossaryoftermsImpuritiesDecisionTreesAnalyticalPostapprovalChangesPACALTSPACALTSChecklistORALTABLETSORALTABLETSTableofContentsHANDBOOKOFGENERICDRUGDEVELOPMENTXVOLUMEHANDBOOKSERIESContentsChapterProcessQualificationBatchProcessQualificationBatchChecklistProcessQualificationBatchSOPsProcessQualificationBlendAnalysisProcessQualificationBlendAnalysisDo'sandDon'tsProcessQualificationQualifyingTabletHardnessTabletHardnessProtocolChapterPivotalbatchThePivotalBatchPivotalbatchChecklistPivotalbatchSOPsSamplingandTestingthePivotalBatchAuditingthePivotalbatchAuditingthePivotalbatchChecklistChapterBioequivalencevsRLDTestDesignsOverviewStatisticalBioequivalenceIBEEquationexplainedIBEBigPicture(ProsandCons)ComparingIBEandABEDissolutionTestinginIRDosageFormsTypicalIVIVCModelsChoosingIVIVClevelsDissolutionTestinginIRSolidDosageFormsSimilarityFactorindissolutiontestingBiowaiversOverallDissolutionPictureBiopharmaceuticsClassificationSystemEvaluatingDifferencesbetweenDrug,PowderBlend,andTabletsPerformanceVerificationinDissolutiontestingFoodEffectsinBABEStudiesSimilarityTestingChow,PittandOthersORALTABLETSORALTABLETSTableofContentsHANDBOOKOFGENERICDRUGDEVELOPMENTXIVOLUMEHANDBOOKSERIESContentsChapterTechnicalTransferDocumentationTechnicalTransferDocumentationDo'sandDon'tsChecklistTechnicalTransferDocumentationPharmaceuticalPartTechnicalTransferDocumentationAnalyticalPartChapterProcessValidationBatchesTheProcessValidationBatchesEssentialknowhowProcessValidationRequirementsSOPsProcessValidationMasterPlansChapterPreApprovalInspectionsPAISummaryPreApprovalInspectionAuditTeamSetUpPreApprovalInspectionAuditTeamActivitiesChapterStabilityTestingofDrugSubstanceandDrugProductIStabilityTestingofDrugSubstanceandDrugProductIIStabilityTestingofDrugSubstanceandDrugProductIIStabilityTestingSignificantChangeStabilityStorageConditionsPhotostabilityinDrugSubstancesSettingupaFunctionalStabilityUnitStabilitySOPsDevelopmentChapterStandardOperationalProceduresDevelopmentSOPsIndexofPharmaceuticalStandardOperatingProceduresIndexofAnalyticalStandardOperatingProceduresIndexofMicrobiologicalStandardOperatingProcedures

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