临床试验英语词汇

专业术语、缩略语中英对照表缩略语英文全称中文全称ABEAverageBioequivalence平均生物等效性ACActivecontrol阳性对照ADEAdverseDrugEvent药物不良事件ADRAdverseDrugReaction药物不良反应AEAdverseEvent不良事件AIAssistantInvestigator助理研究者ALBAlbumin白蛋白ALDApproximateLethalDose近似致死剂量ALPAlkalinephosphatase碱性磷酸酶ALTAlanineaminotransferase丙氨酸转氨酶ANDAAbbreviatedNewDrugApplication简化新药申请ANOVAAnalysisofvariance方差分析ASTAspartateaminotransferase天冬氨酸转氨酶ATRAttenuatedtotalreflection衰减全反射法BABioavailability生物利用度BEBioequivalence生物等效性BMIBodyMassIndex体质指数BUNBloodureanitrogen血尿素氮CATDComputer-assistedtrialdesign计算机辅助试验设计CDERCenterofDrugEvaluationandResearch药品评价和研究中心CFRCodeofFederalRegulation美国联邦法规CICo-Investigator合作研究者CIConfidenceInterval可信区间COICoordinatingInvestigator协调研究者CRCClinicalResearchCoordinator临床研究协调者CRFCaseReport/RecordForm病历报告表/病例记录表CROContractResearchOrganization合同研究组织CSAClinicalStudyApplication临床研究申请CTAClinicalTrialApplication临床试验申请CTPClinicalTrialProtocol临床试验方案CTRClinicalTrialReport临床试验报告CTXClinicalTrialExemption临床试验免责CHMPCommitteeforMedicinal人用药委会ProductsforHumanUseDSCDifferentialscanning差示扫描热量计DSMBDataSafetyandmonitoringBoard数据安全及监控委员会EDCElectronicDataCapture电子数据采集系统EDPElectronicDataProcessing电子数据处理系统EWPEuropeWorkingParty欧洲工作组FDAFoodandDrugAdministration美国食品与药品管理局FRFinalReport总结报告GCPGoodClinicalPractice药物临床试验质量管理规范GCPGoodLaboratoryPractice药物非临床试验质量管理规范GLUGlucose葡萄糖GMPGoodManufacturingPractice药品生产质量管理规范HEVHealtheconomicevaluation健康经济学评价IBInvestigator’sBrochure研究者手册IBEIndividualBioequivalence个体生物等效性ICInformedConsent知情同意ICFInformedConsentForm知情同意书ICHInternationalConferenceonHarmonization国际协调会议IDMIndependentDataMonitoring独立数据监察IDMCIndependentDataMonitoringCommittee独立数据监察委员会IECIndependentEthicsCommittee独立伦理委员会INDInvestigationalNewDrug新药临床研究IRBInstitutionalReviewBoard机构审查委员会ITTIntention-to–treat意向性分析IVDInVitroDiagnostic体外诊断IVRSInteractiveVoiceResponseSystem互动语音应答系统LD50Mediallethaldose半数致死剂量LLOQLowerLimitofquantitation定量下限LOCFLastobservationcarryforward最接近一次观察的结转LOQLimitofQuantitation检测限MAMarketingApproval/Authorization上市许可证MCAMedicinesControlAgency英国药品监督局MHWMinistryofHealthandWelfare日本卫生福利部MRTMeanresidencetime平均滞留时间MTDMaximumToleratedDose最大耐受剂量NDNotdetectable无法定量NDANewDrugApplication新药申请NECNewDrugEntity新化学实体NIHNationalInstitutesofHealth国家卫生研究所（美国）NMRNuclearMagneticResonance核磁共振PDPharmacodynamics药效动力学PIPrincipalInvestigator主要研究者PKPharmacokinetics药物动力学PLProductLicense产品许可证PMAPre-marketApproval(Application)上市前许可（申请）PPPerprotocol符合方案集PSIStatisticiansinthePharmaceuticalIndustry制药业统计学家协会QAQualityAssurance质量保证QAUQualityAssuranceUnit质量保证部门QCQualityControl质量控制QWPQualityWorkingParty质量工作组RARegulatoryAuthorities监督管理部门REVRevision修订SASiteAssessment现场评估SAESeriousAdverseEvent严重不良事件SAPStatisticalAnalysisPlan统计分析计划SARSeriousAdverseReaction严重不良反应SDSourceData/Document原始数据/文件SDSubjectDiary受试者日记SDVSourceDataVerification原始数据核准SELSubjectEnrollmentLog受试者入选表SFDAStateFoodandDrugAdministration国家食品药品监督管理局SISponsor-Investigator申办研究者SISub-investigator助理研究者SICSubjectIdentificationCode受试者识别代码SOPStandardOperatingProcedure标准操作规程SPLStudyPersonnelList研究人员名单SSLSubjectScreeningLog受试者筛选表T&RTestandReferenceProduct受试和参比试剂T－BILTotalBilirubin总胆红素T－CHOTotalCholesterol总胆固醇TGThromboglobulin血小板球蛋白TmaxTimeofmaximumconcentration达峰时间TPTotalproteinum总蛋白UAEUnexpectedAdverseEvent预料外不良事件WHOWorldHealthOrganization世界卫生组织WHO-WHOInternationalConferenceWHO国际药品管理当局会议ICDRAofDrugRegulatoryAuthoritiesAberrantresult异常结果Absorptionphase吸收相Absorption吸收Accuracy准确度Accurate精密度Administer给药Amendment修正案Approval批准Assess估计AuditReport稽查报告Audit稽查Auditor稽查员Analyticalrun/batch：分析批Benefit获益Bias偏性，偏倚Bioequivalence生物等效Biosimilar/Follow-onbiologics生物仿制药BlankControl空白对照Blindcodes编制盲底Blindreview盲态检查/盲态审核Blindingmethod盲法Blinding/masking盲法/设盲Blocksize每段的长度Block层/分段BCS生物药剂学分类系统Carryovereffect延滞效应Casehistory病历Clinicalequivalence临床等效性Clinicalstudy临床研究ClinicalTrialReport临床试验报告Comparison对照Compensation补偿，赔偿金Compliance依从性Concomitant伴随的Conduct行为Confidencelevel置信水平Consistencytest一致性检验Contract/agreement协议／合同Controlgroup对照组CoordinatingCommittee协调委员会Crossoverdesign交叉设计Cross-overStudy交叉研究Cure痊愈Datamanagement数据管理Descriptivestatisticalanalysis描述性统计分析Dichotomies二分类Dispense分布Diviation偏差Documentation记录／文件Dosageforms剂型Dosedumping剂量倾卸（药物迅速释放入血而达到危险浓度）Dose-reactionrelation剂量－反应关系Doubleblinding双盲Doubledummy双模Dropout脱落Effectiveness疗效Eliminationphase消除相Emergencyenvelope应急信件Enantiomers对映体Endpoint终点Endpointcriteria/measurement终点指标Enterohepaticrecycling肠肝循环EssentialDocumentation必需文件Ethical伦理的Ethicscommittee伦理委员会Evaluate评估ExclusionCriteria排除标准Excretion排泄Expedite促进Extrapolated外推的Essentiallysimilarproduct：基本相似药物Factorialdesign析因设计Failure无效，失败Finacing财务，资金Finalpoint终点Firstpassmetabolism首过代谢Fixed-doseprocedure固定剂量法Fullanalysisset全分析集GC－FTIR气相色谱－傅利叶红外联用GC－MS气相色谱－质谱联用Genericdrug通用名药Genemutation基因突变Genotoxicitytests生殖毒性试验Globalassessmentvariable全局评价变量Groupsequentialdesign成组序贯设计Hypothesistest假设检验Highlypermeable：高渗透性Highlysoluble：高溶解度Highlyvariabledrug：高变异性药物Highly：VariableDrug高变异性药物HVDP：高变异药物制剂Identification鉴别，身份证Improvement好转Invitro体外Invivo体内InclusionCriteria入选表准InformationGathering信息收集InitialMeeting启动会议In