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

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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CenterforDrugEvaluationandRese

2、arch(CDER)November1995CMC5药品评价与研究中心1995年n月CMC5TABLEOFCONTENTS目录I.PURPOSEOFGUIDANCE（本指导原则的目的）1II.DEFINITIONOFTERMS（术语定义）3III.COMPONENTSANDCOMPOSITION（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）18VII.I

3、NVITRODISSOLUTION（体外溶出试验）23VIII.INVIVOBIOEQUIVALENCESTUDIES（体内生物等效性）23IX.REFERENCES（参考文献）25APPENDIXA:NARROWTHERAPEUTICRANGEDRUGS（附录A：治疗窗狭窄药物）A-lGUIDANCEFORINDUSTRY1IMMEDIATERELEASESOLIDORALDOSAGEFORMSSCALE-UPANDPOSTAPPROVALCHANGES:CHEMISTRY,MANUFACTURING,ANDCONTROLS,INVI

4、TRODISSOLUTIONTESTING,ANDINVIVOBIOEQUIVALENCEDOCUMENTATION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I.PURPOSEOFGUIDANCE(本指导原贝U的目的)Thisguidanceprovidesrecommendationstosponsorsofnewdrugapplications(NDA's),abbreviatednewdrugapplications(ANDA's),andabbreviatedantibioticap

5、plications(AADA's)whointend,duringthepostapprovalperiod,tochange:1)thecomponentsorcomposition;2)thesiteofmanufacture;3)thescale-up/scale-downofmanufacture;and/or4)themanufacturing(processandequipment)ofanimmediatereleaseoralformulation.木指导原则所提供的的建议适用于新药屮请(NDA's)＞仿制药屮请(AN

6、DA's)和抗生素仿制药中请(AANA'S)的企业的批准后变更，内容包括：1)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Thisguidaneeistheresultof:1)aworkshoponthescale-upofimmediatereleasedrugproductsconductedbytheAmericanAssociationofPharmaceuticalScientistsinconjunctionwiththeUnitedStatesPharmaco

7、poeialConventionandtheFoodandDrugAdministration(FDA);2)researchconductedbytheUniversityofMarylandatBaltimoreonthechemistry,manufacturingandcontrolsofimmediatereleasedrugproductsundertheFDA/UniversityofMarylandManufacturingResearchContract;3)thedrugcategorizationresearchc

8、onductedattheUniversityofMichiganandtheUniversityofUppsalaonthepermeabilityofdrugsubstances;and4)theSca