鼻用制剂FDA标准

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1、GuidanceforIndustryNasalSprayandInhalationSolution,Suspension,andSprayDrugProducts—Chemistry,Manufacturing,andControlsDocumentation`U.S.DepartmentofHealthandHumanServicesFoodandDrugAdministrationCenterforDrugEvaluationandResearch(CDER)July2002CMCGuidan

2、ceforIndustryNasalSprayandInhalationSolution,Suspension,andSprayDrugProducts—Chemistry,Manufacturing,andControlsDocumentationAdditionalcopiesareavailablefrom:OfficeofTrainingandCommunicationsDivisionofDrugInformation,HFD-240CenterforDrugEvaluationandRe

3、searchFoodandDrugAdministration5600FishersLaneRockville,MD20857(Tel)301-827-4573http://www.fda.gov/cder/guidance/index.htmU.S.DepartmentofHealthandHumanServicesFoodandDrugAdministrationCenterforDrugEvaluationandResearch(CDER)July2002CMCTABLEOFCONTENTSI

4、.INTRODUCTION.................................................................................................................1II.BACKGROUND................................................................................................................

5、...2A.NasalSprays.........................................................................................................................2B.InhalationSolutionsandSuspensions..............................................................................

6、.....3C.InhalationSprays..................................................................................................................3III.DRUGPRODUCT..................................................................................................

7、..........5A.FormulationComponents.....................................................................................................5B.FormulationComposition............................................................................................

8、.........5C.SpecificationsfortheFormulationComponents...................................................................5D.Manufacturer.....................................................................................................