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1、DivisionofPharmaceuticalAnalysisCenterforDrugEvaluationandResearchUSFDACindyBuhse,DirectorDisclaimer:ThefindingsandconclusionsinthispresentationhavenotbeenformallydisseminatedbytheFoodandDrugAdministrationandshouldnotbeconstruedtorepresentanyAgencydeterminationorpolicy.Off
2、iceoftheCommissionerFDAOfficeofRegulatoryAffairsCenterforDrugEvaluationand(ORA,field&counterfeitanal.)Research(CDER)CenterforFoodSafetyandCenterforBiologicsEvaluationAppliedNutrition(CFSAN)andResearch(CBER)CenterforVeterinaryMedicineCenterforDevicesand(CVM)RadiologicalHeal
3、th(CDRH)CenterforTobaccoProductsNationalCenterfor(CTP)ToxicologicalResearch(NCTR)2CenterforDrugEvaluationandResearch(CDER)OfficeofNewDrugs(OND)OfficeofCompliance(OC)OfficeofPharmaceuticalScience(OPS)OfficeofNewDrugQualityOfficeofTestingandResearch(OTR)Assessment(ONDQA)Offi
4、ceofGenericDrugs(OGD)DivisionofPharmaceuticalAnalysis(DPA)OfficeofBiotechProducts(OBP)3DivisionofPharmaceuticalAnalysis•Evaluationofanalyticalmethodssubmittedbypharmaceuticalcompanies•Rapidresponseprojects(adverseevents,counterfeits)•Research–Emergingtechnologies•Evaluatio
5、nandnewapplications•Standardsforemergingtechnologies–Methodsdevelopment•Specialdosageforms•Surveillancesamples(postmarketingsafety)–Identity,purity,potency,uniformity,stability,rateofdelivery4LiquidChromatography/MassSpecGasChromatography500MHzNMRDissolutionSpectroscopyApr
6、il7,2011OTRScienceDay56RapidResponse:Heparin•Indications:KidneyDialysis,Surgery,especiallyCardiac-Invasive,HeartAttack,CardiacArrhythmia,AcuteCoronarySyndrome,PulmonaryEmbolism,orStroke,Deep-veinThrombosis,BloodClotPrevention•AdverseEvents:–InearlyJanuary2008,smallclusters
7、ofadverseeventsindialysiscenters.–Manylotsofheparinsodiumwererecalledbythemanufacturersduetoanincreaseintherateofadverseeventswiththeselots.–Seriousreactionsincludeddifficultybreathing,nausea,vomiting,excessivesweating,andrapidlyfallingbloodpressurethatcanleadtolife-threat
8、eningshock.6FoodandDrugAdministration7HeparinRegulatoryHistory•Heparinsodiumisanolddrugwh
