Simulation for designing clinical trials _ a pharmacokinetic-pharmacodynamic modeling perspective.pdfVIP免费

SimulationforDesigningClinicalTrialsAPharmacokinetic-PharmacodynamicModelingPerspectiveHuiC.KimkoJohnson&JohnsonPharmaceuticalResearch&DevelopmentRaritan,NewJersey,U.S.A.StephenB.DuffullUniversityofQueenslandBrisbane,Queensland,AustraliaMARCELMARCELDEKKER,INC.NEWYORKE~ASELD-EKYERCopyright©2003MarcelDekker,Inc.LibraryofCongressCataloging-in-PublicationDataAcatalogrecordforthisbookisavailablefromtheLibraryofCongress.ISBN:0-8247-0862-8Thisbookisprintedonacid-freepaper.HeadquartersMarcelDekker,Inc.270MadisonAvenue,NewYork,NY10016tel:212-696-9000;fax:212-685-4540EasternHemisphereDistributionMarcelDekkerAGHutgasse4,Postfach812,CH-4001Basel,Switzerlandtel:41-61-260-6300;fax:41-61-260-6333WorldWideWebhttp://www.dekker.comThepublisheroffersdiscountsonthisbookwhenorderedinbulkquantities.Formoreinformation,writetoSpecialSales/ProfessionalMarketingattheheadquartersaddressabove.Copyright2003byMarcelDekker,Inc.AllRightsReserved.Neitherthisbooknoranypartmaybereproducedortransmittedinanyformorbyanymeans,electronicormechanical,includingphotocopying,microfilming,andrecording,orbyanyinformationstorageandretrievalsystem,withoutpermissioninwritingfromthepublisher.Currentprinting(lastdigit):10987654321PRINTEDINTHEUNITEDSTATESOFAMERICACopyright©2003MarcelDekker,Inc.ToDennis,Edwin,Jason&Aynsley,andElla&HollyCopyright©2003MarcelDekker,Inc.ForewordComputersimulationsofclinicaltrials,employingrealisticvirtualsubjectsandtypicaltrialconditions,basedonbothexperimentallyinformeddiseaseprogressanddruginterventionmodels,originatedwithinthelastdecade.Previously,clini-caltrialsweredesignedusingadhocempiricalapproaches,unaidedbyasystem-aticclinicalpharmacologyorientationoraquantitativepharmacokinetic-pharma-codynamicframework,leadingtohighlyinefficientdrugdevelopmentprograms.Stimulatedbyresearchandeducationalcontributionsfromacademia,andencour-agementfromregulatoryagencies,expertsimulationteamshaverecentlyde-ployedhundredsofclinicaltrialsimulationprojects.Theadventofmodernclini-caltrialsimulat...