Last observation carry forward,LOCF 最接近一次观察的结转 LC

1、Last observation carry forward, LOCF最接近一次观察的结转LC MS液相色谱一质谱联用LD50 板数致死剂量Logic check逻辑检查LOQ (Limit of Qua ntitatio n)定量限LOCF, Last observatio n 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Missi ng value缺失值Mixed effect model 混合效应模式Mon itor 监查员Mon it

2、or ing监查Mon itor ing report监查报告MRT 平均滞留时间MS 质谱MS MS质谱一质谱联用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 tity, NCE新化学实体New drug applicatio n, NDA 新药申请NMR核磁共振谱Non-cli nical study非临床研究Non-i nf eriority非劣效性Non-parametric statistics非参数统计方法Obedie nee 依从性

3、ODR旋光光谱Open-bli nding非盲Ope n-label非盲原始医疗记录结果指标评价结果指标平行组设计原始医疗记录结果指标评价结果指标平行组设计参数估计 参数统计方法Orig inal medical recordOutcome 结果Outcome assessme ntOutcome measureme ntOutlier 离群值Parallel group desig nParameter estimati onParametric statisticsPatie nt file病人档案Patie nt history 病历Per protocol, PP符合方案集Placeb

4、o 安慰剂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Pr in ciple in vestigator, PI主要研究者Product lice nse, PL产品许可证Protocol试验方案Protocol试验方案Protocol ame ndme nt 方案补正Quality assura nee un it, QAU质量保证部门

5、Quality assura nee, QA 质量保证Quality con trol, QC 质量控制Query list, query form应用疑问表Ran domizatio n随机化Ran domizati on随机Range check 范围检查Rati ng scale 量表Regulatory authorities, RA监督管理部门Replicati on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

6、ordered categorical rat ings有序分类扌旨标Secon dary variable 次要变量Seque nee试验次序Serious adverse event, SAE 严重不良事件Serious adverse reacti on, SAR 严重不良反应Serious ness 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 nding单盲Si ngle-bli ndi ng 单盲Site audit 试验机构稽查SOP 试验室的标准操作规程Source dat

7、a verificatio n, SDV 原始数据核准Source data, SD原始数据Source docume nt, SD原始文件Specificity 特异性Spon sor 申办者Spon sor-i nvestigator 申办研究者Sta ndard curve标准曲线Sta ndard operati ng procedure, SOP标准操作规程Statistic 统计量Statistical an alysis pla n统计分析计划Statistical an alysis plan统计参数计划书Statistical an alysis pla n, SAP统计分析

8、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 en rollme nt受试者入选Subject en rollme nt log受试者入选表Subject ide ntificatio n code, SIC受试者识别代码Subject recruitme nt受试者招募Subject scree ning log受试者筛选表Superiority 检验S

9、urvival an alysis生存分析SXRD 单晶X射线衍射System audit 系统稽查Accuracy 准确度Active con trol, AC阳性对照，活性对照Adverse drug reacti on, 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 reacti on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 s

10、ets统计分析的数据集Approval 批准Assista nt in 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 spection稽查/视察Audit report 稽查报告Auditor 稽查员Bias 偏性，偏倚Bioequivale nee生物等效应Bia nk eon trol空白对照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

11、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 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Cli ni cal equivale nee临床等效应Cli nical study临床研究Cli nical study report临床试验的总结报告Cli nical trial临床试验Cli nical trial applicatio

12、 n, CTA临床试验申请Cli nical trial exemptio n, CTX 临床试验免责 Cli nical trial protocol, CTP临床试验方案Cli nical trial/ study report临床试验报告Cmax 峰浓度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 s

13、iste ncy test一致性检验Co ntraet research orga ni zatio n, CRO合同研究组织Con tract/ agreeme nt协议/合同Con trol group对照组Coord in 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描述性统计分析D

14、F 波动系统Dichotomies 二分类Diviatio n 偏差Docume ntati on记录/文件Dose-reacti on relati on剂量一反应关系Double bli ndi ng双盲Double dummy双模拟Double dummy tech ni que双盲双模拟技术Double-bl in di ng 双盲Drop out 脱落DSC 差示扫描热量计Effective ness疗效Electro nic data capture, EDC电子数据采集系统Electro nic data process ing, EDP电子数据处理系统Emerge ncy en

15、 velope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 ntati on必须文件Ethics committee伦理委员会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 procedure 固定剂量法Forced titratio n强制滴定Full an alysis set全分析集GC FTIR气相色谱一傅利叶红外联用G

16、C MS气相色谱一质谱联用Gen eric drug 通用名药Global assessme nt variable全局评价变量GLU 血糖Good cli nical practice, GCP药物临床试验质量管理规范Good manu facture practice, GMP药品生产质量管理规范Good non-cli nical 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Health eco nomic evaluatio n, HEV健康经济学评价Hypothesis test 假设检验Hy

17、pothesis testi ng假设检验In ter natio nal Co nfere nee of Harmo nizatio n, ICH人用药品注册技术要求国际技术协调会，国际协调会议Improveme nt 好转In clusi on criteria入选标准In depe ndent ethics committee, IEC独立伦理委员会Inf ormatio n con se nt form, ICF知情同意书Inf ormati on gather ing信息收集In formed con se nt, IC知情同意In itial meet ing 启动会议In spection视察/