论文网
数据库有关论文范本,与欧盟《药物流行病学方法学标准指导手册》译介相关毕业论文致谢
本论文是一篇数据库有关毕业论文致谢,关于欧盟《药物流行病学方法学标准指导手册》译介相关毕业论文题目范文。免费优秀的关于数据库及统计分析及药物方面论文范文资料,适合数据库论文写作的大学硕士及本科毕业论文开题报告范文和学术职称论文参考文献下载。
inpharmacoepidemiology[J].ResPharmacoepidemiolDrugSaf,2012,21（1）：1.[10]InternationalEpidemiologicalAssociation（IEA）.Goodepidemiologicalpracticeguidelines[EB/OL].[2010-10-01].http：//ieaweb./category/guidelines-2/.
[11]FuruK,WettermarkB,AndersenM,etal.TheNordiccountriesasacohortforpharmacoepidemiologicalresearch[J].BasicClinPharmacol&Toxicol,2010,106（2）：86.
[12]KielerH,ArtamaM,EngelandA,etal.Selectiveserotoninreuptakeinhibitorsduringpregnancyandriskofpersistentpulmonaryhypertensioninthenewborn：populationbasedcohortstudyfromthefiveNordiccountries[J].BioMedJ,2012,344：d8012.
[13]KimlandE,OdlindV.Off-labeldruguseinpediatricpatients[J].ClinPharmacolTher,2012,91（5）：796.
[14]KahnNF,HarrisonSE,RosePW.Validityofdiagnosticcodingwithinthegeneralpracticeresearchdatabase：asystematicreview[J].BrJGenPract,2010,60（572）：e128.[15]GerhardT.Bias：considerationsforresearchpractice[J].AmJHealthSystPharm,2008,65（22）：2159.
[16]SchneeweissS.Sensitivityanalysisandexternaladjustmentforunmeasuredconfoundersinepidemiologicdatabasestudiesoftherapeutics[J].PharmacoepidemiolDrugSaf,2006,15（5）：291.
[17]MaclureM.Thecase-crossoverdesign：amethodforstudyingtransienteffectsontheriskofacuteevents[J].AmJEpidemiol,1991,133（2）,144.
[18]SchneeweissS,SturmerT,MaclureM.Case-crossoverandcase-time-controldesignsasalternativesinpharmacoepidemiologicresearch[J].PharmacoepidemiolDrugSaf,1997,Suppl3：S51.
[19]WangS,LinkletterC,MaclureM,etal.Future-casesaspresentcontrolstoadjustforexposure-trendbiasincase-onlystudies[J].Epidemiol,2011,22：568.
[20]WeldeselassieYG,WhitakerHJ,FarringtonCP.Useoftheself-controlledcase-seriesmethodinvaccinesafetystudies：reviewandremendationsforbestpractice[J].EpidemiolInfect,2011,139（12）：1805.
[21]BrookhartMA,RassenJA,SchneeweissS.Instrumentalvariablemethodsinparativesafetyandeffectivenessresearch[J].PharmacoepidemiolDrugSaf,2010,19（6）：537.
[22]BateA,EvansSJW.QuantitativesignaldetectionusingspontaneousADRreporting[J].PharmacoepidemiolDrugSaf,2009,18（6）：427.
[23]EudravigilanceExpertWorkingGroup（EV-EWG）.Guidelineontheuseofstatisticalsignaldetectionmethodsintheeudravigilancedataanalysissystem[EB/OL].[2008-12-01].http：//.ema.europa.eu/docs/en_GB/document_library/Regulatory_and_procedural_guideline/2009/11/WC500011434.pdf.
[24]RosenbaumPR.Designofobservationalstudies[M].Berlin：Springer,2010.
[25]InternationalCommitteeofMedicalJournalEditors（ICJME）.Uniformrequirementsformanuscriptssubmittedtobiomedicaljournals[EB/OL].[2010-12-31].http：//.icmje./urm_main..
TranslationandintroductionofGuidetoMethodological
StandardsinPharmacoepidemiology
TIANFeng1,LIAOXing2,XIEYan-ming2*
（1.Post-DoctoralStationofChinaAcademyofChineseMedicalSciences,Beijing100700,China；
2.InstituteofBasicResearchinClinicalMedicine,ChinaAcademyofChineseMedicalSciences,Beijing100700,China）
[Abstract]Post-marketingpharmacovigilanceofdrugshasbeeoneofthemostimportantactivitiesforregulatoryauthorities.InChina,pharmacovigilanceiscurrentlyreceivingtheattentionofgovernment,pharmaceuticalindustriesandthepublic.Inordertosupporthighqualitypharmacoepidemiologicalstudiesandtostimulateinnovationthatbenefitspatientsandthewiderpublic,theEuropeanmedicinesagency（EMA）anizedtheEuropeanworkofcentresforpharmacoepidemiologyandpharmacovigilance（ENCePP）toformulateandpublishtheGuideonMethodologicalStandardsinPharmacoepidemiologyasareferencedocumentforthemethodologicalstandardsofpharmacovigilanceactivitiesintheEuropeanunion（EU）.Itsuppliesmethodologicalandscientificguidance,andadvisesontechnicalaspectsofconductingparmacoepidemiologicalstudiesandundertakingparmacovigilance.Asadviceincludes：legalandethicalrequirements,generalaspectsofstudyprotocols,researchquestions,approachestodatacollection,studydesignsandmethods,statisticalandepidemiologicalanalysisplans,qualitycontrolandqualityassurance,reportingofadverseeventstoregulatoryauthorities,municationoffindings,andsoon.Thetranslationandintroductionofthisguidancecanprovideausefultechnicalandmethodologicalreferenceforustocarryoutthepharmacovigilance（especiallyforparenterallyadministeredChinesemedicinesafetymonitoring）.
[Keywords]Europeanunion；pharmacoepidemiology；pharmacovigilance；methodologicalstandards
doi：10.4268/cjcmm20131807
数据库有关论文范本,与欧盟《药物流行病学方法学标准指导手册》译介相关毕业论文致谢参考文献资料：