药物临床试验常用英文.docx

1、药物临床试验常用英文Accuracy准确度Active control，AC阳性对照，活性对照Adverse drug reaction，ADR药物不良反应Adverse event，AE不良事件Adverse medical events不良医学事件Adverse reaction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 spending function消耗函数ALT丙氨酸氨基转换酶Analysis sets统计分析的数据集Approval批准Assistant investigator助理研究者AST天门冬酸氨

2、基转换酶ATR衰减全反射法AUCss稳态血药浓度时间曲线下面积Audit稽查Audit or inspection稽查视察Audit report稽查报告Auditor稽查员Bias偏性，偏倚Bioequivalence生物等效应Blank control空白对照Blind codes编制盲底Blind review盲态审核Blind review盲态检查Blinding method盲法Blinding/ masking盲法，设盲Block分段Block层Block size每段的长度BUN尿素氮Carryover effect延滞效应Case history病历Case report fo

3、rm病例报告表Case report form/ case record form，CRF病例报告表，病例记录表Categorical variable分类变量Cav平均浓度CD圆二色谱CL清除率Clinical equivalence临床等效应Clinical study临床研究Clinical study report临床试验的总结报告Clinical trial临床试验Clinical trial application，CTA临床试验申请Clinical trial exemption，CTX临床试验免责Clinical trial protocol，CTP临床试验方案Clinical

4、 trial/ study report临床试验报告Cmax峰浓度Co-investigator合作研究者Comparison对照Compliance依从性Composite variable复合变量Computer-assisted trial design，CATD计算机辅助试验设计Confidence interval可信区间Confidence level置信水平Consistency test一致性检验Contract research organization，CRO合同研究组织Contract/ agreement协议合同Control group对照组Coordinating

5、committee协调委员会Crea肌酐CRF（case report form）病例报告表Crossover design交叉设计Cross-over study交叉研究Css稳浓度Cure痊愈Data management数据管理Database建立数据库Descriptive statistical analysis描述性统计分析DF波动系统Dichotomies二分类Diviation偏差Documentation记录文件Dose-reaction relation剂量反应关系Double blinding双盲Double dummy双模拟Double dummy technique双

6、盲双模拟技术Double-blinding双盲Drop out脱落DSC差示扫描热量计Effectiveness疗效Electronic data capture，EDC电子数据采集系统Electronic data processing，EDP电子数据处理系统Emergency envelope应急信件End point终点Endpoint criteria/ measurement终点指标Equivalence等效性Essential documentation必须文件Ethics committee伦理委员会Excellent显效Exclusion criteria排除标准Factori

7、al design析因设计Failure无效，失败Final point终点Fixed-dose procedure固定剂量法Forced titration强制滴定Full analysis set全分析集GCFTIR气相色谱傅利叶红外联用GCMS气相色谱质谱联用Generic drug通用名药Global assessment 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

8、，GLP药物非临床研究质量管理规范Group sequential design成组序贯设计Health economic evaluation，HEV健康经济学评价Hypothesis test假设检验Hypothesis testing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Inclusion 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

9、Information gathering信息收集Informed consent，IC知情同意Initial meeting启动会议Inspection视察检查Institution inspection机构检查Institution review board，IBR机构审查委员会Intention to treat意向治疗（临床领域）Intention-totreat，ITT意向性分析（统计学）Interactive voice response system，IVRS互动式语音应答系统Interim analysis期中分析Investigator研究者Investigators bro

10、chure，IB研究者手册IR红外吸收光谱Ka吸收速率常Last observation carry forward，LOCF最接近一次观察的结转LCMS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Marketing approval/ authorization上市许可证Matched pair匹配配对Missing value缺失值Mixed effect model混合效应模式Moni

11、tor监查员Monitoring监查Monitoring report监查报告MRT平均滞留时间MS质谱MSMS质谱质谱联用MTD（Maximum Tolerated Dose）最大耐受剂量Multicenter trial多中心试验Multi-center trial多中心试验New chemical entity，NCE新化学实体New drug application，NDA新药申请NMR核磁共振谱Non-clinical study非临床研究Non-inferiority非劣效性Non-parametric statistics非参数统计方法Obedience依从性ODR旋光光谱Ope

12、n-blinding非盲Open-label非盲Optional titration随意滴定Original medical record原始医疗记录Outcome结果Outcome assessment结果指标评价Outcome measurement结果指标Outlier离群值Parallel group design平行组设计Parameter estimation参数估计Parametric statistics参数统计方法Patient file病人档案Patient history病历Per protocol，PP符合方案集Placebo安慰剂Placebo control安慰剂对

13、照Polytomies多分类Power检验效能Precision精密度Preclinical study临床前研究Primary endpoint主要终点Primary variable主要变量Principal investigator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 assurance unit，QAU质量保证部门Quality assurance，QA质量保证Quality control，QC质量控

14、制Query list，query form应用疑问表Randomization随机化Randomization随机Range check范围检查Rating scale量表Regulatory authorities，RA监督管理部门Replication可重复RSD日内和日间相对标准差Run in准备期Safety evaluation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Scale of ordered categorical ratings有序分类指标Secondary variable次要变量Sequenc

15、e试验次序Serious adverse event，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Significant level检验水准Simple randomization简单随机Single blinding单盲Single-blinding单盲Site audit试验机构稽查SOP试验室的标准操作规程Source data verification，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

16、办者Sponsor-investigator申办研究者Standard curve标准曲线Standard operating procedure，SOP标准操作规程Statistic统计量Statistical analysis plan统计分析计划Statistical analysis plan统计参数计划书Statistical analysis plan，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-investigator助理研究者Subje

17、ct受试者Subject diary受试者日记Subject enrollment受试者入选Subject enrollment log受试者入选表Subject identification code，SIC受试者识别代码Subject recruitment受试者招募Subject screening log受试者筛选表Superiority检验Survival analysis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TBIL总胆红素TCHO总胆固醇TG热重分析TLC、HPLC制备色谱Tmax峰时间TP总蛋白Tr

18、ansformation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 blinding三盲Two one-side test双单侧检验Unblinding揭盲Unblinding破盲Unexpected adverse event，UAE预料外不良事件UVVIS紫外可见吸收光谱Variability变异Variable变量Visual analogy scale直观类比打分法Visual check人工检查Vulnerable subject弱势受试者Wash-out清洗期Washout period洗脱期Well-being福利，健康