mould and sweeney mab review current opinion

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1、84Thepharmacokineticsandpharmacodynamicsofmonoclonalantibodies–mechanisticmodelingappliedtodrugdevelopmentDianeRMould*&KevinRDSweeneyAddressantibody-fusionproteins.Currently,therearemorethan20ProjectionsResearchIncantibodyproductsapprovedforusebytheFDA.A535SpringviewLanesummaryof

2、thebroadcharacteristicsoftheseagentsisPhoenixvillePA19460providedinTable1.USAEmail:drmould@attglobal.netInmanycases,pharmacokineticandpharmacodynamic(PK-PD)modelinghasexpeditedthedevelopmentofthese*TowhomcorrespondenceshouldbeaddressedmAbsandhasbeenutilizedtosupporttheselectionof

3、theCurrentOpinioninDrugDiscovery&Development200710(1):84-96doseregimen[2•].Inarecentreview,asignificant©TheThomsonCorporationISSN1367-6733proportionofnewdrugapplications(42of244applicationssurveyed)includedstudiesofPK-PDThepharmacologyoftherapeuticmonoclonalantibodies(mAbs)modeli

4、ngofthedrug,andofthosethatdidincludeiscomplexanddependantonboththestructureoftheantibodymodeling,morethanhalfwereconsideredcriticaltotheandthephysiologicalsystemthatittargets.Patientexposureapprovalandlabelingofthedrug[3•].ModelingandandresponsestomAbsarealsorelatedtothestructure

5、andsimulationevaluationarethereforebecomingmoreactivityofmAbs.Furthermore,thepharmacokineticsandcommonlyusedduringdrugdevelopment.AconceptusedpharmacodynamicsofmAbsareofteninter-related.indrugdevelopmentthathasbeenwidelyacceptedinthePharmacokineticandpharmacodynamicmodelinghavebe

6、enusedtoelucidateorsupportthemechanismsofantibodiesinpharmaceuticalindustryandtermedthe'learnanddevelopmentandcanbeusedtoidentifyappropriatedoseconfirm'approachbenefitsstronglyfrommodelingandregimens.Consequently,pharmacokineticandpharmacodynamicsimulationmethodologies[4].Thiscon

7、ceptespeciallymodelingoftenplaysalargerroleduringthedevelopmentofbenefitsfromtheuseofmoresophisticatedmodelstherapeuticmAbsthanforsmallmolecules.combiningboththeconcentration-timecharacteristics(PK)ofacandidatedrugandtheeffect-concentrationKeywordsmAb,mechanisticmodeling,pharmaco

8、dynamics,characteristics(PD)ofthedrugres