药物临床试验常用英文

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1、Accuracy?准确度Active control, ?AC字日性对照，活性对照Adverse drug reaction , ?ADR药物不良反应Adverse eve nt , ?AE?不 良事件Adverse medical eve nts?不良医学事件Adverse reactio n? 药物不良反应Alb?白蛋白ALD (Approximate Lethal Dose )?近似致死剂量ALP?碱性磷酸酶Alpha spe nding fun cti on?消耗函数ALT?丙氨酸氨基转换酶An alysis sets?统计分析的数据集Approval?批准Assista nt in

2、vestigator? 助理研究者AST?天门冬酸氨基转换酶ATR?衰减全反射法AUCss稳态血药浓度一时间曲线下面积Audit?稽查Audit or in spectio n?稽查/视察Audit report? 稽查报告Auditor?稽查员Bias?偏性，偏倚Bioequivalenee?生物等效应Bia nk eon trol?空白对照Blind codes?编制盲底Bli nd review? 盲态审核Bli nd review? 盲态检查Bli ndi ng method?盲法Bli nding/ mask ing? 盲法，设盲Block?分段Block?层Block size?每

3、段的长度BUN尿素氮Carryover effect?延滞效应Case history? 病历Case report form? 病例报告表Case report form/ case record form,?CRF病例报告表，病例记录表临床研究临床试验Categorical variable?Cav?平均浓度CD圆二色谱CL?清除率Cli ni cal equivale nee?Cli nical study?Cli ni cal study report?Cli nical trial?Cli nical trial applicati onCli ni cal trial exempt

4、i onCli nical trial protocolCli ni cal trial/ study report?Cmax峰浓度分类变量临床等效应临床试验的总结报告，?CTA?临床试验申请，?CTX临床试验免责，?CTP?临床试验方案临床试验报告Co-i nvestigator?合作研究者Comparis on?对照Complia nee?依从性Composite variable? 复合变量Computer-assisted trial desig n,?CATD计算机辅助试验设计Con fide nee in terval?可信区间Con fide nee level?置信水平Con

5、siste ncy test?致性检验Contract research organization, ?CRO合同研究组织Con tract/ agreeme nt?协议/合同Control group?对照组Coordin ati ng committee?协调委员会Crea?肌酐CRF( case report form )?病例报告表Crossover desig n?交叉设计Cross-over study?交叉研究Css?稳浓度Cure?痊愈Data man ageme nt?数据管理Database?建立数据库Descriptive statistical an alysis?描述

6、性统计分析DF?波动系统Dichotomies?二分类Diviatio n?偏差Documentation?记录/文件Dose-reacti on relatio n?剂量-反应关系Double bli ndi ng?双盲Double dumm y?双模拟Double dummy tech niq ue?双盲双模拟技术Double-bli ndin g?双盲Drop out?脱落DSC差示扫描热量计Effective ness?疗效Electr onic data capture,?EDC电子数据米集系统Electr onic data process ing,?EDP电子数据处理系统Emer

7、gency envelope?应急信件End point?终点En dpo int criteria/ measureme nt?终点指标Equivale nee?等效性Esse ntial docume ntatio n?必须文件Ethics committee? 伦理委员会Excellent?显效Exclusi on criteria?排除标准Factorial desig n?析因设计Failure?无效，失败Final poi nt?终点Fixed-dose procedure?固定剂量法Forced titratio n?强制滴定Full a nalysis set? 全分析集GO

8、FTIR?气相色谱傅利叶红外联用GO MS气相色谱质谱联用Gen eric drug?通用名药Global assessme nt variable?全局评价变量GLU血糖Good clinical practice , ?GCP药物临床试验质量管理规范Good manufacture practice , ?GMP药品生产质量管理规范Good non-clinical laboratory practice, ?GLP?药物非临床研究质量管理规范Group seque ntial desig n?成组序贯设计In terim an alysis?期中分析Hypothesis test?假设检

9、验Hypothesis test in g?假设检验International Conference of Harmonization, ?ICH?人用药品注册技术要求国际技术协调会，国际协调会议Improvement?好转In clusio n criteria?入选标准Independent ethics committee， ?IEC?独立伦理委员会Information consent form， ?ICF?知情同意书In formatio n gatheri ng?信息收集In formed con se nt ， ?IC?知情同意In itial meet ing?启动会议Insp

10、ection?视察/检查In stituti on in specti on?机构检查Institution review board， ?IBR?机构审查委员会In te ntion to treat?意向治疗（？临床领域）Intention-to?- treat ， ?ITT?意向性分析（一？统计学）In teractive voice resp onse system，?IVRS?互动式语音应答系统In vestigator?研究者Investigators brochure, ?IB?研究者手册IR?红外吸收光谱Ka?吸收速率常Last observation carry forwar

11、d , ?LOCF最接近一次观察的结转LC MS液相色谱质谱联用LD50?板数致死剂量Logic check?逻辑检查LOQ?(Limit of Quantitation) ?定量限LOCF ?Last observation carry forward? 最近一次观察的结转Lost of follow up? 失访Marketi ng approval/ authorizati on?上市许可证Matched pair?匹配配对Miss ing value?缺失值Mixed effect model?混合效应模式Monitor?监查员Monitoring?监查Mon itori ng rep

12、ort?监查报告MRT平均滞留时间MS质谱MS- MS质谱-质谱联用MTD( Maximum Tolerated Dose ) ?最大耐受剂量Multiee nter trial?多中心试验Multi-ee nter trial?多中心试验New chemical en tity，?NCE新化学实体New drug applicatio n，?NDA新药申请NMR核磁共振谱Non-cli ni cal study?非临床研究Non-i nferiority?非劣效性Non-parametric statistics?非参数统计方法Obedie nee?依从性ODR旋光光谱Open-blindi

13、ng?非盲Open-label?非盲Optio nal titratio n?随意滴定Original medical record? 原始医疗记录Outcome?吉果Outcome assessment? 结果指标评价Outcome measureme nt?结果指标Outlier?离群值Parallel group desig n?平行组设计Parameter estimatio n?参数估计Parametric statistics?参数统计方法Patie nt file?病人档案Patie nt history?病历Per protocol , ?PP?符合方案集Placebo?安慰剂

14、Placebo con trol?安慰剂对照Polytomies?多分类Power?检验效能Precision?精密度Precli nical study?临床前研究Primary en dpo int?主要终点Primary variable?主要变量Pri ncipal in vestigator?主要研究者Principle investigator, ?PI?主要研究者Product license , ?PL?产品许可证Protocol?试验方案Protocol?试验方案Protocol amendment?方案补正Quality assuranee unit, ?QAU质量保证部门

15、Quality assuranee， ?QA质量保证Quality control ，?QC质量控制Query list ，?query form?应用疑问表Randomization?随机化Randomization?随机Range check?范围检查Rati ng scale?量表Regulatory authorities ，?RA?监督管理部门Replicatio n?可重复RSD日内和日间相对标准差Run in?准备期Safety evaluatio n?安全性评价Safety set?安全性评价的数据集Sample size?样本含量Sample size?样本量，样本大小Sca

16、le of ordered categorical rati ngs?有序分类指标Seco ndary variable?次要变量Seque nee?试验次序Serious adverse eve nt ， ?SAE严重不良事件Serious adverse reaction ， ?SAR严重不良反应Seriousness?严重性Severity?严重程度Signi fica nt level?检验水准Simple ran domizati on? 简单随机Si ngle bli ndi ng?单盲Sin gle-bli ndi ng?单盲Site audit? 试验机构稽查SOP试验室的标准

17、操作规程Source data verificatio n,?SDV原始数据核准Source data , ?SD?原始数据Source document , ?SD?原始文件Specificity?特异性Sponsor?申办者Sponsor-in vestigator?申办研究者Standard curve?标准曲线Stan dard operati ng procedureStatistic?统计量Statistical an alysis pla n?Statistical an alysis pla n?Statistical an alysis pla n，?SOP标准操作规程统计分

18、析计划统计参数计划书，?SAP?统计分析计划Statistical model? 统计模型Statistical tables?统计分析表Stratified?分层Study audit?研究稽查Subgroup?亚组Sub-i nvestigator?助理研究者Subject?受试者Subject diary? 受试者日记Subject e nrollme nt?受试者入选Subject e nrollme nt log?受试者入选表Subject identification code , ?SIC?受试者识别代码Subject recruitme nt?受试者招募Subject scre

19、e ning log?受试者筛选表Superiority?检验Survival a nalysis?生存分析SXRD单晶X射线衍射System audit?系统稽查T1/2?消除半衰期Target variable? 目标变量T BIL?总胆红素T CHO总胆固醇TG?热重分析TLC HPLC制备色谱Tmax?峰时间TP?总蛋白Transformation?变量变换Treatment group?试验组Trial error?试验误差Trial master file?试验总档案Trial objective?试验目的Trial site?试验场所Triple bli nding?三盲Two on e-side test?双单侧检验Unblinding?揭盲Unblinding?破盲Un expected adverse eve nt， ?UAE预料外不良事件UV VIS?紫外一可见吸收光谱Variability?变异Variable?变量Visual a nalogy scale? 直观类比打分法Visual check? 人工检查Vul nerable subject?弱势受试者Wash-out?清洗期Washout period?洗脱期Well-being?福利，健康