美国ANDA片剂(IR)开发模板-1(中英文对照)

ExampleQbDIRTabletModule3Quality3.2.P.2PharmaceuticalDevelopmentIR片剂QbD实例模块3质量3.2.P.2药物开发2012年4月1QualitybyDesignforANDAs:AnExampleforImmediate-ReleaseDosageFormsANDAs的质量源于设计：速释制剂的实例IntroductiontotheExample实例简介ThisisanexamplepharmaceuticaldevelopmentreportillustratinghowANDAapplicantscanmovetowardimplementationofQualitybyDesign(QbD).ThepurposeoftheexampleistoillustratethetypesofpharmaceuticaldevelopmentstudiesANDAapplicantsmayuseastheyimplementQbDintheirgenericproductdevelopmentandtopromotediscussiononhowOGDwouldusethisinformationinreview.这是一个有关药物开发报告的实例，用以说明ANDA申请人如何实施质量源于设计(QbD)。该实例的目的是说明ANDA申请人在其仿制药开发过程中实施QbD时，可使用的药物开发研究的类型，同时促进探讨OGD在审评中如何使用该信息。Althoughwehavetriedtomakethisexampleasrealisticaspossible,thedevelopmentofarealproductmaydifferfromthisexample.Theexampleisforillustrativepurposesand,dependingonapplicants’experienceandknowledge,thedegreeofexperimentationforaparticularproductmayvary.Theimpactofexperienceandknowledgeshouldbethoroughlyexplainedinthesubmission.Theriskassessmentprocessisoneavenueforthisexplanation.Atmanyplacesinthisexample,alternativepharmaceuticaldevelopmentapproacheswouldalsobeappropriate.虽然我们已试图让实例尽可能切合实际，但真实产品的开发可能与该实例不同。该实例是用于说明的目的，并取决于申请人的经验和知识，个别产品的实验程度可能会有所不同。在提交时应充分说明经验和知识的作用。风险评估过程是该解释的一个途径。该实例的许多地方，也可适用其他药物开发方法。Notestothereaderareincludedinital[e-mail]整篇文章的斜体内容为致读者的内容。如有任何问题和意见，请发送至[e-mail]。ExampleQbDIRTabletModule3Quality3.2.P.2PharmaceuticalDevelopmentIR片剂QbD实例模块3质量3.2.P.2药物开发2012年4月2PharmaceuticalDevelopmentReportExampleQbDforIRGenericDrugsIR仿制药的药物开发报告的QbD实例___________________________________________________________________________TableofContents目录表1.1ExecutiveSummary概述1.2AnalysisoftheReferenceListedDrugProduct分析参考列表药品1.2.1Clinical临床1.2.2Pharmacokinetics药动学1.2.3DrugRelease药物释放1.2.4PhysicochemicalCharacterization理化性质1.2.5Composition成分1.3QualityTargetProductProfilefortheANDAProductANDA药品的目标药品质量概述1.4DissolutionMethodDevelopmentandPilotBioequivalenceStudies溶出方法开发和中试生物等效性研究1.4.1DissolutionMethodDevelopment溶出方法开发1.4.2PilotBioequivalenceStudy中试生物等效性研究2.1ComponentsofDrugProduct制剂成分2.1.1DrugSubstance原料药2.1.1.1PhysicalProperties物理性质2.1.1.2ChemicalProperties化学性质2.1.1.3BiologicalProperties生物学性质2.1.2Excipients辅料2.1.2.1ExcipientCompatibilityStudies辅料相容性研究2.1.2.2ExcipientGradeSelection辅料级别选择2.2DrugProduct制剂2.2.1FormulationDevelopment处方开发2.2.1.1InitialRiskAssessmentoftheFormulationVariables处方变量的初始风险评估2.2.1.2DrugSubstanceParticleSizeSelectionforProductDevelopment制剂开发中的原料药粒径选择2.2.1.3ProcessSelection工艺选择2.2.1.4FormulationDevelopmentStudy#1处方开发研究#12.2.1.5FormulationDevelopmentStudy#2处方开发研究#22.2.1.6FormulationDevelopmentConclusions处方开发结论2.2.1.7UpdatedRiskAssessmentoftheFormulationVariables更新的处方变量风险评估2.2.2Overages过量投料2.2.3PhysicochemicalandBiologicalProperties理化和生物学性质2.3ManufacturingProcessDevelopment生产工艺开发2.3.1InitialRiskAssessmentoftheDrugProductManufacturingProcess制剂生产工艺的初始风险评估2.3.2Pre-RollerCompactionBlendingandLubricationProcessDevelopment预碾压混合和润滑工艺开发2.3.3RollerCompactionandIntegratedMillingProcessDevelopment碾压和集成粉碎工艺开发2.3.4FinalBlendingandLubricationProcessDevelopment昀终混合和润滑工艺开发ExampleQbDIRTabletModule3Quality3.2.P.2PharmaceuticalDevelopmentIR片剂QbD实例模块3质量3.2.P.2药物开发2012年4月32.3.5TabletCompressionProcessDevelopment压片工艺开发2.3.6Scale-UpfromLabtoPilotScaleandCommercialScale从实验室规模放大至中试规模和工业规模2.3.6.1Scale-UpofthePre-RollerCompactionBlendingandLubricationProcess预碾压混合和润滑工艺的放大2.3.6.2Scale-UpoftheRollerCompactionandIntegratedMillingProcess碾压和集成粉碎工艺的放大2.3.6.3Scale-UpoftheFinalBlendingandLubricationProcess昀终混合和润滑工艺的放大2.3.6.4Scale-UpoftheTabletCompressionProcess压片工艺的放大2.3.7ExhibitBatch申报批2.3.8UpdatedRiskAssessmentoftheDrugProductManufacturingProcess更新的制剂生产工艺风险评估2.4ContainerClosureSystem容器密封系统2.5MicrobiologicalAttributes微生物属性2.6Compatibility相容性2.7ControlStrategy控制策略2.7.1ControlStrategyforRawMaterialAttributes原材料属性的控制策略2.7.2ControlStrategyforPre-RollerCompactionBlendingandLubrication预碾压混合和润滑的控制策略2.7.3ControlStrategyforRollerCompactionandIntegratedMilling碾压和集成粉碎的控制策略2.7.4ControlStrategyforFinalBlendingandLubrication昀终混合和润滑的控制策略2.7.5ControlStrategyforTabletCompression压片的控制策略2.7.6ProductLifecycleManagementandContinualImprovement产品生命周期管理和持续改进ListofAbbreviations缩略语表ExampleQbDIRTabletModule3Quality3.2.P.2PharmaceuticalDevelopmentIR片剂QbD实例模块3质量3.2.P.2药物开发2012年4月41.1ExecutiveSummary概述ThefollowingpharmaceuticaldevelopmentreportsummarizesthedevelopmentofGenericAcetriptanTablets,20mg,agenericversionofthereferencelisteddrug(RLD),BrandAcetriptanTablets,20mg.TheRLDisanimmediaterelease(IR)tabletindicatedforthereliefofmoderatetoseverephysiologicalsymptoms.WeusedQualitybyDesign(QbD)todevelopgenericacetriptanIRtabletsthataretherapeuticallyequivalenttotheRLD.总结了如下药物开发报告，开发20mgAcetriptan片的仿制药，一种商品名20mgAcetriptan片的参考目录药物(RLD)的仿制药。RLD为速释(IR)片，用于缓解中度至重度生理症状。我们使用质量源于设计(QbD)法用以开发与RLD治疗等效的acetriptanIR片的仿制药。Initially,thequalitytargetproductprofile(QTPP)wasdefinedbasedonthepropertiesofthedrugsubstance,characterizationoftheRLDproduct,andconsideration