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 controlAC阳性对照，活性对照Adverse drug reacti onADR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 reacti on 药物不良反应Alb 白蛋白ALD (Approximate Lethal Dose ) 近似致死剂量消耗函数ALP碱性磷酸酶Alpha spending fun cti onALT丙氨酸氨基转换酶An alysis sets 统计分析的数据集App roval 批准AST天门冬酸氨基转换酶ATR衰减

2、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 re port 稽查报告Auditor 稽查员Bias 偏性，偏倚Bioequivale nee 生物等效应Bli nd codes 编制盲底Bli nd review 盲态审核Bli nd review 盲态检查Bli nding method 盲法Bli nding/ mask ing 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 form

3、 病例报告表Cav平均浓度CD圆二色谱CL清除率Cli nical study 临床研究Cmax峰浓度Co-i nv estigator 合作研究者Comp aris on 对照Comp lia nee 依从性Comp osite variable 复合变量Con fide nee in terval 可信区间Con fide nee level 置信水平CRO合同研究组织Con tract research orga ni zati onCon tract/ agreeme nt 协议/合同Con trol gro up 对照组Coord in at ing committee 协调委员会C

4、rea肌酐CRF( case rep ort form ) 病例报告表Css稳浓度Cure痊愈Data man ageme nt数据管理描述性统计分析Database 建立数据库Descri ptive statistical an alysisDF波动系统Dichotomies 二分类Diviatio n 偏差Docume ntati on 记录/文件Double bli nding 双盲Double dummy 双模拟Double dummy tech ni que 双盲双模拟技术Double-bli ndi ng 双盲Drop out 脱落DSC差示扫描热量计Effective ness

5、 疗效Emerge ncy envelope 应急信件终点指标End point 终点Endpoint criteria/ measureme ntEquivale nee 等效性Esse ntial docume ntatio n 必须文件Excelle nt 显效Exclusi on criteria排除标准Factorial desig n析因设计Failure 无效，失败Final point 终点Fixed-dose p rocedure 固定剂量法GC- FTIR气相色谱-傅利叶红外联用GC- MS气相色谱-质谱联用全局评价变量Gen eric drug 通用名药Global as

6、sessme nt variableGLU血糖Good cli nical p racticeGCP药物临床试验质量管理规范Good manu facture p racticeGMP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HEV健康经济学评价Group seque ntial desig n 成组序贯设计Health econo mic evaluati onHyp othesis test 假设检验Hyp othesis test ing 假设检验International Conference o

7、f 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Impro veme nt 好转In formed consent , IC 知情同意In itial meet ing启动会议机构检查Insp ection 视察/检查In stituti on insp ecti onInv estigator 研究者IR红外吸收光谱Ka吸收速率常LC- MS液相色谱质谱联用LD50板数致死剂量Logic check 逻辑检查定量限最近一次观察的结转LOQ (Limit of Qua ntitatio n )LOCF Last observati on carry

8、 forwardLost of follow up失访上市许可证Marketi ng appro val/ authorizati onMatched pair 匹配配对Missi ng value 缺失值Mixed effect model 混合效应模式Mon itor 监查员Mon itori ng 监查Mon itori ng report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Multice nter trial多中心试验Multi-ce nter trial多中心试验New chemical en

9、tityNCE新化学实体New drug app licati onNDA新药申请NMR核磁共振谱Obedie nee 依从性ODR旋光光谱Open-bli nding 非盲Open-label 非盲Outcome 结果Outcome measurement 结果指标Outlier 离群值P arameter estimati on 参数估计Placebo 安慰剂Polytomies 多分类Power检验效能P recisi on 精密度Protocol 试验方案Protocol 试验方案Ran domizatio n 随机化Ran domizati on 随机Range check 范围检查

10、Rati ng scale 量表Rep licatio n 可重复RSD日内和日间相对标准差Run in 准备期Safety evaluation 安全性评价有序分类指标Scale of ordered categorical rat ingsSecondary variable 次要变量Sequenee 试验次序SAR严重不良反应Serious adverse reacti onSerious ness 严重性Severity 严重程度Sim pie ran domizati on 简单随机Si ngle bli nding 单盲Si ngle-bli ndi ng 单盲Site audit

11、 试验机构稽查SOP试验室的标准操作规程Source data verificati onSDV原始数据核准Source data ， SD 原始数据Source document， SD 原始文件Sp ecificity 特异性Spon sor 申办者Sponsor-inv estigator 申办研究者Sta ndard curve 标准曲线Stan dard op erat ing p rocedureSOP标准操作规程Statistic 统计量Statistical an alysis plan统计分析计划Statistical an alysis plan统计参数计划书Statist

12、ical an alysis planSAP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Subgro up 亚组Sub-i nvestigator 助理研究者Subject 受试者Subject diary 受试者日记Subject en rollme nt 受试者入选SIC受试者识别代码Subject ide ntificati on codeSubject recruitme nt 受试者招募Subject scree ning log受试者筛选表Sup eriority 检验

13、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Tran sformatio n 变量变换Treatme nt group 试验组Trial error 试验误差Trial site 试验场所Two on e-side test 双单侧检验Un bli ndi ng 揭盲Un bli ndi ng 破盲Unexp ected adverse eve nt , UAE 预料外不良事件U 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-bei ng 福利