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1、BayesianMethodsinPharmacovigilance*UniversityPressScholarshipOnlineOxfordScholarshipOnlineBayesianStatistics9JoséM.Bernardo,M.J.Bayarri,JamesO.Berger,A.P.Dawid,DavidHeckerman,AdrianF.M.Smith,andMikeWestPrintpublicationdate:2011PrintISBN-13:9780199694587PublishedtoOxfordScholarshipOnline:January2
2、012DOI:10.1093/acprof:oso/9780199694587.001.0001BayesianMethodsinPharmacovigilance*DavidMadiganPatrickRyanShawnSimpsonIvanZorychDOI:10.1093/acprof:oso/9780199694587.003.0014AbstractandKeywordsRegulatorssuchastheU.S.FoodandDrugAdministrationhaveelaborate,multi‐yearprocessesforapprovingnewdrugsass
3、afeandeffective.Nonetheless,inrecentyears,severalapproveddrugshavebeenwithdrawnfromthemarketbecauseofseriousandsometimesfatalsideeffects.Wedescribestatisticalmethodsforpost‐approvaldataanalysisthatattempttodetectdrugsafetyproblemsasquicklyaspossible.Bayesianapproachesareespeciallyusefulbecauseof
4、thehighdimensionalityofthedata,and,inthefuture,forincorporatingdisparatesourcesofinformation.Keywords:Drugsafety,Shrinkage,High‐dimensionalmodeling,PoissonregressionPage1of22BayesianMethodsinPharmacovigilance*SummaryRegulatorssuchastheU.S.FoodandDrugAdministrationhaveelaborate,multi‐yearprocesse
5、sforapprovingnewdrugsassafeandeffective.Nonetheless,inrecentyears,severalapproveddrugshavebeenwithdrawnfromthemarketbecauseofseriousandsometimesfatalsideeffects.Wedescribestatisticalmethodsforpost‐approvaldataanalysisthatattempttodetectdrugsafetyproblemsasquicklyaspossible.Bayesianapproachesaree
6、speciallyusefulbecauseofthehighdimensionalityofthedata,and,inthefuture,forincorporatingdisparatesourcesofinformation.KeywordsandPhrases:DRUGSAFETY;SHRINKAGE;HIGH‐DIMENSIONALMODELING;POISSONREGRESSION.1.IntroductionIncreasingscientific,regulatoryandpublicscrutinyfocusesontheobligationofthemedical
7、community,pharmaceuticalindustryandhealthauthoritiestoensurethatmarketeddrugshaveacceptablebenefit‐riskprofiles.Thisisanintricateandongoingprocessthatbeginswithcarefullydesignedrandomizedclinicaltrialspriortoapprovalbutconti
