应用群体方法评价生物等效性精品课件.pptVIP

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应用群体方法评价生物等效性精品课件.ppt

UsingthePopulationApproachforBioequivalenceAssessmentChuanpuHu,PhDDirector,PharmacometricsBiologicsClinicalPharmacologyCentocorResearchDevelopment,Inc.2ndISQP,Xiamen,China,2010

Bioequivalence(BE)objectivesPopulationmodelingapproachesExploratory:CommonbutconflictswithBEobjectivesConfirmatory:NewlyproposedHowtoimplementApplicationexampleConclusionOutline

Rateandextentofabsorption,assessedwithCmaxandAUCBEcriterion:evaluateratiosforCmaxandAUC,i.e.,90%confidenceintervalfallingwithin80-125%Analysismodel(SAScode):logCmaxlogAUC=SEQPERT

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