翻译(SUPAC-IR指导原则：速释口服固体制剂：放大生产和批准后变更).docx

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1、GuidanceforIndustryImmediateReleaseSolidOralDosageFormsScale-UpandPostapprovalChanges:Chemistry,Manufacturing,andControls,InVitroDissolutionTesting,andInVivoBioequivalenceDocumentationSUPAC-IR指导原则：速释口服固体制剂放大生产和批准后变更：化学、生产和控制，体外溶出试验、体内生物等效性文件Centerfor

2、DrugEvaluationandResearch(CDER)November1995CMC5药品评价与研究中心1995年11月CMC5TABLEOFCONTENTS目录I.PURPOSEOFGUIDANCE（本指导原则的目的）......................................1II.DEFINITIONOFTERMS（术语定义）...............................................3III.COMPONENTSANDCOMPOS

3、ITION（辅料成分或组成的变更）..........................6IV.SITECHANGES（地点变更）......................................................13V.CHANGESINBATCHSIZE(SCALE-UP/SCALE-DOWN)（批量大小（放大/缩小）的变更）......16VI.MANUFACTURING（生产变更）...........................................

4、........18VII.INVITRODISSOLUTION（体外溶出试验）..........................................23VIII.INVIVOBIOEQUIVALENCESTUDIES（体内生物等效性）.............................23IX.REFERENCES（参考文献）......................................................25APPENDIXA:NARROWTHE

5、RAPEUTICRANGEDRUGS（附录A：治疗窗狭窄药物）.........A-1GUIDANCEFORINDUSTRY1IMMEDIATERELEASESOLIDORALDOSAGEFORMSSCALE-UPANDPOSTAPPROVALCHANGES:CHEMISTRY,MANUFACTURING,ANDCONTROLS,INVITRODISSOLUTIONTESTING,ANDINVIVOBIOEQUIVALENCEDOCUMENTATION速释口服固体制剂放大生产和批准后变更：化学、

6、生产和控制，体外溶出试验、体内生物等效性文件I.PURPOSEOFGUIDANCE（本指导原则的目的）Thisguidanceprovidesrecommendationstosponsorsofnewdrugapplications(NDA's),abbreviatednewdrugapplications(ANDA's),andabbreviatedantibioticapplications(AADA's)whointend,duringthepostapprovalperiod,toch

7、ange:1)thecomponentsorcomposition;2)thesiteofmanufacture;3)thescale-up/scale-downofmanufacture;and/or4)themanufacturing(processandequipment)ofanimmediatereleaseoralformulation.本指导原则所提供的的建议适用于新药申请（NDA's）、仿制药申请（ANDA's）和抗生素仿制药申请（AANA’S）的企业的批准后变更，内容包括：1）

8、成分或组分的变更；2）生产地点的变更；3）放大/缩小生产规模的变更；和/或4）生产过程（工艺和设备）的变更Thisguidanceistheresultof:1)aworkshoponthescale-upofimmediatereleasedrugproductsconductedbytheAmericanAssociationofPharmaceuticalScientistsinconjunctionwiththeUnitedStatesPharmacopoeialConventionan