FDA PowerPoint Presentation - U S Food and Drug Administration.ppt


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Selectionofantibioticsforacuteotitismedia:,MD,PhDProfessorofPathologyCaseWesternReserveUniversityDirectorofClinicalMicrobiologyUniversityHospitalsofClevelandCleveland,–20001––891990–911992–931994–951997199819992000Year%PenicillinresistantResistantMIC>g/mlIntermediateMIC=–g/;99(suppl6B):3S–;43:1901–,posterC--1999Hyde,TB,;286:1857-:susceptibilityofmiddleearfluidisolatesintwotimeperiods*AgentMIC90(ug/ml)%Susceptible*1973-851995-981973-85AmoxicillinAmox->416>2>410010010010098989192545563631995-98*BasedonPK/PDbreakpointsJacobsMPIDJ2000;19:S471973-85:N=50;1995-98:N=:susceptibilityofmiddleearfluidisolatesintwotimeperiods*AgentMIC90(ug/ml)%Susceptible*1973-851995-981973-85AmoxicillinAmox-clavCefuroximeCefprozilClarithomycinAzithromycin>>81216162841009462254977614001995-98*BasedonPK/PDbreakpointsJacobsMPIDJ2000;19:S471973-85:N=50;1995-98:N=(ear,sinusorlungtap)toobtainspecimenMoststudiesarethereforedesignedtoshow“equivalent”;120:72–(halfthepatientswouldbeineacharmofastudy);120:72–:pared1-e1,3onewasbacteriologicdiagnosis,e4Patientagesinthesestudiesdiffered:–15yearsold(mean4–6years),-4years()Samplesizedrequiredforstudiestobepoweredtoshowdifferencesbetweenagentsweredeterminedba

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  • 页数31
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  • 上传人aena45
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  • 时间2020-02-20