欧美医药常用缩略词注解文档格式.docx
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欧美医药常用缩略词注解文档格式.docx
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ACTGAIDSClinicalTrialsGroup(NIAID)
ACTUAIDSClinicalTrialsUnit(NIH)
ADaMAnalysisDatasetModel(CDISC)
ADAMHAAlcohol,DrugAbuse,andMentalHealthAdministration(nolongerexists)
ADEadversedrugevent;
adversedrugeffect
ADMEabsorption,distribution,metabolism,andexcretion(usedtodescribepharmacokineticprocesses)
ADRadversedrugreaction
AEadverseevent
AEGISADROITElectronicallyGeneratedInformationService,asubscriptionservicethatprovidessubscribingorganizationswithaccesstoadversedrugreactiondatafromtheMedicinesControlAgency’sADROIT(AdverseDrugReactionOn-lineInformationTracking)database.
AERSAdverseEventReportingSystem(FDA)
AFCRSeeAFMR
AFMRAmericanFederationforMedicalResearch,formerlytheAmericanFederationforClinicalResearch(AFCR)
AHAAmericanHeartAssociation
AHCPRAgencyforHealthCarePolicyResearch(NIH)
AICRCAssociationofIndependentClinicalResearchContractors(UK)
AIDSAcquiredimmunedeficiencysyndrome
ALCOA
attributable,legible,contemporaneous,original,accurate(dimensionsofdataquality)
AMAAmericanMedicalAssociation
AMCantibody-mediatedcytotoxicity
AmFARAmericanFoundationforAIDSResearch
AMGArzneimittelgesetz(GermanDrugLaw)
AMWAAmericanMedicalWritersAssociation
ANDAAbbreviatedNewDrugApplication(foragenericdrug)
ANOVAanalysisofvariance(statistics)
ANSIAmericanNationalStandardsInstitute
AOACAssociationofOfficialAnalyticalChemists
APBAssociationPharmaceutiqueBelge(Belgium)
APhAAmericanPharmacistsAssociation
APIactivepharmaceuticalingredient
ARCSAssociationofRegulatory&
ClinicalScientists(Australia)
ARENAAppliedResearchEthicsNationalAssociation
AROacademicresearchorganization
ASAP
administrativesystemsautomationproject(FDA)
ASCIIAmericanStandardCodeforInformationInterchange(computerfiles)
ASCPTAmericanSocietyforClinicalPharmacologyandTherapeutics
ASQ
AmericanSocietyforQuality,formerlyAmericanSocietyforQualityControl
AUC
areaunderthecurve(statistics)
AZTzidovudine(HIVtreatment)
BARQABritishAssociationofResearchQualityAssurance
BCEbeneficialclinicalevent
BDPABureauofDrugPolicyandAdministration(China)
BEUCEuropeanBureauofConsumerUnions
BfArM
Bundesinstrtutfü
rArzneimittelundMedizinprodukte(FederalInstituteforDrugsandMedicalDevices,Germany)
BGA
Bundesgesundheitsamt(Federalhealthoffice;
formerGermanpublichealthagency)
BGVV
Bundesinstitutfü
rgesundheitlichenVerbraucherschutzund
Veterinarmedizin(FederalInstituteforHealthProtectionofConsumersand
VeterinaryMedicine,Germany)
BIOBiotechnologyIndustryOrganization
BIRABritishInstituteofRegulatoryAffairs
BLABiologicsLicenseApplication(FDA)
BPIBundesverbandderPharmazeutischenIndustrieEV(Germany)
BrAPPBritishAssociationofPharmaceuticalPhysicians
BSAbodysurfacearea
CACompetentAuthority(regulatorybodychargedwithmonitoringcompliancewithEuropeanUnionmemberstatenationalstatutesandregulations)
CAPRACanadianAssociationofPharmaceuticalRegulatoryAffairs
CASChemicalAbstractsService
CBERCenterforBiologicsEvaluationandResearch(FDA)
CCICommitteeonClinicalInvestigations.SeealsoEthicsCommitteeboxinTermsGlossary.
CCPPRBComité
ConsultativepourlaProtectiondesPersonnesdanslesRecherchesBiomé
dicales(France).SeealsoEthicsCommitteebox.
CCRACertifiedClinicalResearchAssociate.CertificationissuedtomonitorsbyACRP.
CCRCCertifiedClinicalResearchCoordinator.CertificationissuedtoclinicalcoordinatorsbyACRP.
CCRPCertifiedClinicalResearchProfessional.SOCRAcertificationofcoordinators,monitors,andotherresearchprofessionals.
CDAclinicaldocumentarchitecture
CDCCentersforDiseaseControlandPrevention
CDERCenterforDrugEvaluationandResearch(FDA)
CDISCClinicalDataInterchangeStandardsConsortium
CDMclinicaldatamanagement
CDRHCenterforDevicesandRadiologicalHealth(FDA)
CENComiteEuropeendeNormalisation(EuropeanCommitteeforStandardization)
CEUcontinuingeducationunit
CFconsentform
CFHConnectingforHealth
CFRCodeofFederalRegulations(usuallycitedbytitleandpart;
forexample,Title21,Part211isshownas21CFR211)
cGMPcurrentgoodmanufacturingpractices
CHIConsolidatedHealthInitiative(eGov)
CHRCommitteeonHumanResearch.SeealsoEthicsCommitteebox.
CIOMSCouncilforInternationalOrganisationsofMedicalSciences(postapprovalinternationalADRreporting,UK)
CIPCertifiedIRBProfessional
CISCommonwealthofIndependentStates
CLIAClinicalLaboratoryImprovementsAmendments
Cmaxconcentrationmaximum;
usedinpharmacokineticsandbioequivalencetoindicatemaximumplasmaconcentrationforadrug
CMCchemistry,manufacturing,andcontrol
CMEcontinuingmedicaleducation
CNScentralnervoussystem
COPCDISCoperatingprocess/procedure
COSTARTCodingSymbolsforaThesaurusofAdverseReactionTerms.SeealsoMedDRA.
CPHSCommitteefortheProtectionofHumanSubjects
CPMPCommitteeforProprietaryMedicinalProducts(EU)
CPSCConsumerProductSafetyCommission(U.S.)
CRAclinicalresearchassociate.SeealsoCCRA
CRADAcooperativeresearchanddevelopmentagreement(withNIH)
CRBcaserecordbook
CRBcentralreviewboard
CRCclinicalresearchcoordinator.SeealsoCCRC,SC,SSC.
CRFcasereportform(sometimescaserecordform)
CROcontractresearchorganization.SeealsoIPRO.
CSDDCenterfortheStudyofDrugDevelopment
CSFCollaborativeStandardsForum(CDISC)
CSFcerebrospinalfluid
CSFcolonystimulatingfactor
CSMCommitteeonSafetyofMedicines(UK)
CSOConsumerSafetyOfficer(FDA)
CSRclinicalstudyreport
CSUclinicalsupplyunit
CTclinicaltrial
CTAclinicaltrialagreement
CTCclinicaltrialcertificate(UK)
CTDcommontechnicaldocument
CTEPcancertherapyevaluationprogram
CTMclinicaltrialsmaterials
CTXclinicaltrialexemption(MCA)
CVcurriculumvitae
CVMCenterforVeterinaryMedicine(FDA)
DAWNDrugAbuseWarningNetwork
DDDepartmentofDrugs(Swedishregulatoryagency)
DEADrugEnforcementAdministration(U.S.)
DENDrugExperienceNetwork
DESDataEncryptionStandard
DESIDrugEfficacyStudyImplementationnotice(FDA,toevaluatedrugsinusebefore1962)
DGPharMedDeutscheGesellschaftfü
rPharmazeutischeMedizin(GermanSocietyofPharmaceuticalMedicine),formerlyFAPI
DHEWDepartmentofHealth,EducationandWelfare(U.S.,nowsplitintoDHHSandDepartmentofEducation)
DHHSDepartmentofHealthandHumanServices(U.S.)
DHTMLdynamicHTML(IT)
DIADrugInformationAssociation
DICOMDigitalImagingandCommunicationsinMedicine
DLTdose-limitingtoxicity
DMBDataManagementBiomedical(France)
DoDDepartmentofDefense(U.S.)
DPC-PTRActDrugPriceCompetitionandPatentTermRestorationActof1984(alsoWaxman-HatchorHatch-Waxmanbill)
DSIDivisionofScientificInvestigations(FDA)
DSMDiagnosticandStatisticalManual(oftheAmericanPsychiatricAssociation)
DSMBDataandSafetyMonitoringBoard
DSNPdevelopmentofstandardizednomenclatureproject(FDA)
DTCdirect-to-consumer(drugadvertising)
DTDdocumenttypedefinition(XML)
E3CEuropeanCDISCCoordinatingCommittee
EABEditorialAdvisoryBoard(AppliedClinicalTrials)
EABEthicaladvisoryboard.SeealsoEthicsCommitteebox.
ECethicscommittee.SeealsoEthicsCommitteebox.
ECEuropeanCommission(indocumentsolderthanthemid-1980s,ECmaymeanEuropeanCommunity)
ECGelectrocardiogram
ECGEuropeanCDISCGroup
ECJEuropeanCourtofJustice
ECOGEasternCooperativeOncologyGroup(U.S.)
ECPHINEuropeanCommunityPharmaceuticalProductsInformationNetwork
eCRFelectroniccasereportform
EDCelectronicdatacapture/collection
EDIelectronicdatainterchange
EECEuropeanEconomicCommunity,nowEU;
someregulatorydocumentsstillhaveEECdocumentnumbers
EFGCPEuropeanForumforGoodClinicalPractice
EFPIAEuropeanFederationofPharmaceuticalIndustriesandAssociations
EFTAEuropeanFreeTradeAssociation
EIREstablishmentInspectionReport(FDA)
ELAEstablishmentLicenseApplication(FDA)
EMEAEuropeanAgencyfortheEvaluationofMedicinalProducts
EMSelectronicmailservice
EMWAEuropeanMedicalWritersAssociation
EORTCEuropeanOrganizationfortheResearchandTreatmentofCancer
EPEuropeanParliament
EPAREuropeanPublicAssessmentReport
EPOEuropeanPatentOffice
EPRGEuropeanPharmacovigilanceResearchGroup
EREssentialRequirements(EMEA)
ESRAEuropeanSocietyofRegulatoryAffairs
ESTRIElectronicStandardsfortheTransferofRegulatoryInformation(ICH)
EUEuropeanUnion
EUDRAEuropeanUnionDrugRegulatoryAuthoriti
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