臨床試驗(yàn)英語詞匯

專業(yè)術(shù)語、縮略語中英對照表縮略語英文全稱中文全稱ABEAverageBioequivalence平均生物等效性ACActivecontrol陽性對照ADEAdverseDrugEvent藥物不良事件ADRAdverseDrugReaction藥物不良反應(yīng)AEAdverseEvent不良事件AIAssistantInvestigator助理研究者ALBAlbumin白蛋白ALDApproximateLethalDose近似致死劑量ALPAlkalinephosphatase堿性磷酸酶ALTAlanineaminotransferase丙氨酸轉(zhuǎn)氨酶ANDAAbbreviatedNewDrugApplication簡化新藥申請ANOVAAnalysisofvariance方差分析ASTAspartateaminotransferase天冬氨酸轉(zhuǎn)氨酶ATRAttenuatedtotalreflection衰減全反射法BABioavailability生物利用度BEBioequivalence生物等效性BMIBodyMassIndex體質(zhì)指數(shù)BUNBloodureanitrogen血尿素氮CATDComputer-assistedtrialdesign計(jì)算機(jī)輔助試驗(yàn)設(shè)計(jì)CDERCenterofDrugEvaluationandResearch藥品評價和研究中心CFRCodeofFederalRegulation美國聯(lián)邦法規(guī)CICo-Investigator合作研究者CIConfidenceInterval可信區(qū)間COICoordinatingInvestigator協(xié)調(diào)研究者CRCClinicalResearchCoordinator臨床研究協(xié)調(diào)者CRF CaseReport/RecordForm 病歷報告表/病例記錄表CRO ContractResearchOrganization 合同研究組織CSA ClinicalStudyApplication 臨床研究申請CTA ClinicalTrialApplication 臨床試驗(yàn)申請CTP ClinicalTrialProtocol 臨床試驗(yàn)方案CTR ClinicalTrialReport 臨床試驗(yàn)報告CTX ClinicalTrialExemption 臨床試驗(yàn)免責(zé)CHMP CommitteeforMedicinal 人用藥委會ProductsforHumanUseDSC Differentialscanning 差示掃描熱量計(jì)DSMB DataSafetyandmonitoringBoard 數(shù)據(jù)安全及監(jiān)控委員EDC ElectronicDataCapture 電子數(shù)據(jù)采集系統(tǒng)EDP ElectronicDataProcessing 電子數(shù)據(jù)處理系統(tǒng)EWP EuropeWorkingParty 歐洲工作組FDA FoodandDrugAdministration 美國食品與藥品管理局FR FinalReport 總結(jié)報告GCP GoodClinicalPractice 藥物臨床試驗(yàn)質(zhì)量管理規(guī)范GCP GoodLaboratoryPractice 藥物非臨床試驗(yàn)質(zhì)量管理規(guī)GLU Glucose 葡萄糖GMP GoodManufacturingPractice 藥品生產(chǎn)質(zhì)量管理規(guī)范HEV Healtheconomicevaluation 健康經(jīng)濟(jì)學(xué)評價IB Investigator’sBrochure 研究者手冊IBE IndividualBioequivalence 個體生物等效IC InformedConsent 知情同意ICF InformedConsentForm 知情同意書ICH InternationalConferenceonHarmonization國際協(xié)調(diào)會議IDM IndependentDataMonitoring 獨(dú)立數(shù)據(jù)監(jiān)IDMC IndependentDataMonitoringCommittee 獨(dú)立數(shù)據(jù)監(jiān)察委員會IECIndependentEthicsCommittee獨(dú)立倫理委員會INDInvestigationalNewDrug新藥臨床研究IRBInstitutionalReviewBoard機(jī)構(gòu)審查委員會ITTIntention-totreat意向性分析IVDInVitroDiagnostic體外診斷IVRSInteractiveVoiceResponseSystem互動語音應(yīng)答系統(tǒng)LD50Mediallethaldose半數(shù)致死劑量LLOQLowerLimitofquantitation定量下限LOCFLastobservationcarryforward最接近一次觀察的結(jié)轉(zhuǎn)LOQLimitofQuantitation檢測限MAMarketingApproval/Authorization上市許可證MCAMedicinesControlAgency英國藥品監(jiān)督局MHWMinistryofHealthandWelfare日本衛(wèi)生福利部MRTMeanresidencetime平均滯留時間MTDMaximumToleratedDose最大耐受劑量NDNotdetectable無法定量NDANewDrugApplication新藥申請NECNewDrugEntity新化學(xué)實(shí)體NIHNationalInstitutesofHealth國家衛(wèi)生研究所（美國）NMRNuclearMagneticResonance核磁共振PDPharmacodynamics藥效動力學(xué)PIPrincipalInvestigator主要研究者PKPharmacokinetics藥物動力學(xué)PLProductLicense產(chǎn)品許可證PMAPre-marketApproval(Application)上市前許可（申請）PPPerprotocol符合方案集PSIStatisticiansinthePharmaceuticalIndustry制藥業(yè)統(tǒng)計(jì)學(xué)家協(xié)會QAQualityAssurance質(zhì)量保證QAUQualityAssuranceUnit質(zhì)量保證部門QCQualityControl質(zhì)量控制QWPQualityWorkingParty質(zhì)量工作組RARegulatoryAuthorities監(jiān)督管理部門REVRevision修訂SASiteAssessment現(xiàn)場評估SAESeriousAdverseEvent嚴(yán)重不良事件SAPStatisticalAnalysisPlan統(tǒng)計(jì)分析計(jì)劃SARSeriousAdverseReaction嚴(yán)重不良反應(yīng)SDSourceData/Document原始數(shù)據(jù)/文件SDSubjectDiary受試者日記SDVSourceDataVerification原始數(shù)據(jù)核準(zhǔn)SELSubjectEnrollmentLog受試者入選表SFDAStateFoodandDrugAdministration國家食品藥品監(jiān)督管理局SISponsor-Investigator申辦研究者SISub-investigator助理研究者SICSubjectIdentificationCode受試者識別代碼SOPStandardOperatingProcedure標(biāo)準(zhǔn)操作規(guī)程SPLStudyPersonnelList研究人員名單SSLSubjectScreeningLog受試者篩選表T&RTestandReferenceProduct受試和參比試劑T－BILTotalBilirubin總膽紅素T－CHOTotalCholesterol總膽固醇TGThromboglobulin血小板球蛋白TmaxTimeofmaximumconcentration達(dá)峰時間TPTotalproteinum總蛋白UAEUnexpectedAdverseEvent預(yù)料外不良事件WHOWorldHealthOrganization世界衛(wèi)生組織WHO-WHOInternationalConferenceWHO國際藥品管理當(dāng)局會議ICDRAofDrugRegulatoryAuthoritiesAberrantresultAbsorptionphase吸收相Absorption吸收Accuracy準(zhǔn)確度Accurate精密度Administer給藥Amendment修正案Approval批準(zhǔn)Assess估計(jì)AuditReport稽查報告Audit稽查Auditor稽查員Analyticalrun/batch：分析批Benefit獲益Bias偏性，偏倚Bioequivalence生物等效Biosimilar/Follow-onbiologics生物仿制藥BlankControl空白對照Blindcodes編制盲底Blindreview盲態(tài)檢查/Blindingmethod盲法Blinding/masking盲法/設(shè)盲Blocksize每段的長度Block層/分段BCS 生物藥劑學(xué)分類系統(tǒng)Carryovereffect延滯效應(yīng)Casehistory病歷Clinicalequivalence臨床等效性Clinicalstudy臨床研究ClinicalTrialReport臨床試驗(yàn)報告Comparison對照CompensationCompliance依從性Concomitant伴隨的Conduct行為Confidencelevel置信水平Consistencytest一致性檢驗(yàn)Contract/agreementControlgroup對照組CoordinatingCommittee協(xié)調(diào)委員會Crossoverdesign交叉設(shè)計(jì)Cross-overStudyCure痊愈Datamanagement數(shù)據(jù)管理Descriptivestatisticalanalysis描述性統(tǒng)計(jì)分析DichotomiesDispense分布Diviation偏差Documentation記錄／文件Dosageforms劑型Dosedumping 劑量傾卸（藥物迅速釋放入血而達(dá)到危險濃度）Dose-reactionrelation劑量－反應(yīng)關(guān)系Doubleblinding雙盲Doubledummy雙模Dropout脫落Effectiveness療效EliminationphaseEmergencyenvelope應(yīng)急信件Enantiomers對映體Endpoint終點(diǎn)Endpointcriteria/measurementEnterohepaticrecycling腸肝循環(huán)EssentialDocumentation必需文件Ethical倫理的Ethicscommittee倫理委員會Evaluate評估ExclusionCriteria排除標(biāo)準(zhǔn)Excretion排泄Expedite促進(jìn)Extrapolated 外推Essentiallysimilarproduct：基本相似藥物FactorialdesignFailure無效，失敗Finacing財務(wù)，資金Finalpoint終點(diǎn)Firstpassmetabolism首過代謝Fixed-doseprocedureFullanalysisset全分析集GC－FTIR氣相色譜－傅利葉紅外聯(lián)用GC－MS氣相色譜－質(zhì)譜聯(lián)用Genericdrug通用名藥Genemutation基因突變Genotoxicitytests生殖毒性試驗(yàn)Globalassessmentvariable全局評價變Groupsequentialdesign成組序貫設(shè)計(jì)Hypothesistest 假設(shè)檢驗(yàn)Highlypermeable：高滲透性Highlysoluble：高溶解度Highlyvariabledrug：高變異性藥物Highly：VariableDrugHVDP：高變異藥物制劑Identification鑒別，身份證Improvement好轉(zhuǎn)Invitro體外Invivo體內(nèi)InclusionCriteria入選表準(zhǔn)InformationGatheringInitialMeeting啟動會議Inspection檢察/視察InstitutionInspection機(jī)構(gòu)檢察Instruction指令，說明Integrity完整，正直Intercurrent中間發(fā)生的，間發(fā)的Inter-individualvariability 個體間變異性Interimanalysis期中分析InvestigationalProductInvestigator研究者Involve引起，包括IR紅外吸收光譜InnovatorProduct：原創(chuàng)藥Ka吸收速率常LC－MS液相色譜－質(zhì)譜聯(lián)用logarithmictransformationLogiccheck邏輯檢查Lostoffollowup失訪Mask面具，掩飾MatchedpairMetabolism代謝Missingvalue缺失值Mixedeffectmodel混合效應(yīng)模式ModifiedreleaseproductsMonitor監(jiān)查員MonitoringPlan監(jiān)察計(jì)劃MonitoringReport監(jiān)察報告MS－MS質(zhì)譜－質(zhì)譜聯(lián)用Multi-centerTrialNegative陰性，否定的Non-clinicalStudy非臨床研究Non-inferiority非劣效性Non-LinearPharmacokineticsNon-parametricstatistics非參數(shù)統(tǒng)計(jì)方法NTID：窄治療指數(shù)制劑Obedience依從性O(shè)pen-blindingOpen-label非盲OriginalMedicalRecord原始醫(yī)療記錄OutcomeAssessment結(jié)果評價Outcomemeasurement結(jié)果指標(biāo)Outlier離群值OIP經(jīng)口服吸收藥物Parallelgroupdesign平行組設(shè)計(jì)Parameterestimation參數(shù)估計(jì)ParametricstatisticsPatientfile病人檔案PatientHistory病歷Perprotocol，PP符合方案集Permeability滲透性PharmacodynamiccharacteristicsPharmacokineticcharacteristics藥代學(xué)特征PlaceboControl安慰劑對照Placebo安慰劑Polytomies多分類Post-dosingpostures給藥后坐姿Potential潛在的Power檢驗(yàn)效能PrecisionPreclinicalStudyPrecursor母體前體Premature過早的，早發(fā)Primaryendpoint主要終點(diǎn)Primaryvariable主要變量Prodrug藥物前體ProtocolamendmentProtocolAmendments修正案Protocol試驗(yàn)方案QualityControlSampleRapidlydissolving：快速溶出Racemates外消旋物Randomization隨機(jī)化Rangecheck范圍檢Ratingscale量表RecruitReplication可重復(fù)Retrieval取回，補(bǔ)修Revise修正Risk風(fēng)險Runin準(zhǔn)備期Safetyevaluation安全性評價Safetyset安全性評價的數(shù)據(jù)集SampleSizeSamplingschedules采血計(jì)劃Scaleoforderedcategoricalratings有序分類指標(biāo)Secondaryvariable次要變量Sequence試驗(yàn)次序Seriousness嚴(yán)重性Severity嚴(yán)重程度Significantlevel檢驗(yàn)水準(zhǔn)Simplerandomization簡單隨機(jī)SingleBlinding單盲Siteaudit試驗(yàn)機(jī)構(gòu)稽查Solubility溶解度Specificity特異性Specify敘述，說明Sponsor-investigatorStandardcurve標(biāo)準(zhǔn)曲線Statisticalmodel統(tǒng)計(jì)模型Statisticaltables統(tǒng)計(jì)分析表Steadystate穩(wěn)態(tài)Storage儲存Stratified分層StudyAuditStudySite研究中心Subgroup亞組Sub-investigator助理研究者SubjectEnrollmentLog受試者入選表SubjectEnrollment受試者入選SubjectIdentificationCodeList受試者識別代碼表SubjectRecruitment受試者招募SubjectScreeningLogSubject受試者Submit交付，委托Superiority檢驗(yàn)SupplementalSupra-bioavailability超生物利用度（試驗(yàn)藥的生物利用度大于對照藥）Survivalanalysis生存分析SystemAudit系統(tǒng)稽查SmPC：藥品說明書StandardSampleTargetvariable目標(biāo)變量Treatmentgroup試驗(yàn)組Trialerror試驗(yàn)誤差TrialInitialMeetingTrialMasterFile試驗(yàn)總檔案TrialObjective試驗(yàn)?zāi)康腡rialsite試驗(yàn)場所TripleBlinding三盲Twoone-sidetest雙單側(cè)檢驗(yàn)TherapeuticequivalenceUn-blinding破盲揭盲Verify查證、核實(shí)VisualanalogyscaleVulnerablesubject弱勢受試者Wash-outPeriod洗脫期Well-bei