临床试验英语词汇

临床试验英语词汇
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

ABE Average Bioequivalence 平均生物等效性

AC Active control 阳性对照

ADE Adverse Drug Event 药物不良事件

ADR Adverse Drug Reaction 药物不良反应

AE Adverse Event 不良事件

AI Assistant Investigator 助理研究者

ALB Albumin 白蛋白

ALD Approximate Lethal Dose 近似致死剂量

ALP Alkaline phosphatase 碱性磷酸酶

ALT Alanine aminotransferase 丙氨酸转氨酶ANDA Abbreviated New Drug Application 简化新药申请ANOV A Analysis of variance 方差分析

AST Aspartate aminotransferase 天冬氨酸转氨酶ATR Attenuated total reflection 衰减全反射法

BA Bioavailability 生物利用度

BE Bioequivalence 生物等效性

BMI Body Mass Index 体质指数

BUN Blood urea nitrogen 血尿素氮

CA TD Computer-assisted trial design 计算机辅助试验设计CDER Center of Drug Evaluation and Research 药品评价和研究中心CFR Code of Federal Regulation 美国联邦法规

CI Co-Investigator 合作研究者

CI Confidence Interval 可信区间

COI Coordinating Investigator 协调研究者

CRC Clinical Research Coordinator 临床研究协调者

CRF Case Report/Record Form 病历报告表/病例记录表

CRO Contract Research Organization 合同研究组织

CSA Clinical Study Application 临床研究申请

CTA Clinical Trial Application 临床试验申请

CTP Clinical Trial Protocol 临床试验方案

CTR Clinical Trial Report 临床试验报告

CTX Clinical Trial Exemption 临床试验免责

CHMP Committee for Medicinal 人用药委会

Products for Human Use

DSC Differential scanning 差示扫描热量计

DSMB Data Safety and monitoring Board 数据安全及监控委员会

EDC Electronic Data Capture 电子数据采集系统

EDP Electronic Data Processing 电子数据处理系统

EWP Europe Working Party 欧洲工作组

FDA Food and Drug Administration 美国食品与药品管理局

FR Final Report 总结报告

GCP Good Clinical Practice 药物临床试验质量管理规范GCP Good Laboratory Practice 药物非临床试验质量管理规范GLU Glucose 葡萄糖

GMP Good Manufacturing Practice 药品生产质量管理规范

HEV Health economic evaluation 健康经济学评价

IB Investigator’s Brochure研究者手册

IBE IndividualBioequivalence 个体生物等效性

IC Informed Consent 知情同意

ICF Informed Consent Form 知情同意书

ICH International Conference on Harmonization 国际协调会议

IDM Independent Data Monitoring 独立数据监察

IDMC Independent Data Monitoring Committee 独立数据监察委员会

IEC Independent Ethics Committee 独立伦理委员会

IND Investigational New Drug 新药临床研究

IRB Institutional Review Board 机构审查委员会

ITT Intention-to –treat 意向性分析

IVD In Vitro Diagnostic 体外诊断

IVRS Interactive Voice Response System 互动语音应答系统

LD50 Medial lethal dose 半数致死剂量

LLOQ Lower Limit of quantitation 定量下限

LOCF Last observation carry forward 最接近一次观察的结转LOQ Limit of Quantitation 检测限

MA Marketing Approval/Authorization 上市许可证

MCA Medicines Control Agency 英国药品监督局

MHW Ministry of Health and Welfare 日本卫生福利部

MRT Mean residence time 平均滞留时间

MTD Maximum Tolerated Dose 最大耐受剂量

ND Not detectable 无法定量

NDA New Drug Application 新药申请

NEC New Drug Entity 新化学实体

NIH National Institutes of Health 国家卫生研究所(美国)NMR Nuclear Magnetic Resonance 核磁共振

PD Pharmacodynamics 药效动力学

PI Principal Investigator 主要研究者

PK Pharmacokinetics 药物动力学

PL Product License 产品许可证

PMA Pre-market Approval (Application) 上市前许可(申请)

PP Per protocol 符合方案集

PSI Statisticians in the Pharmaceutical Industry 制药业统计学家协会QA Quality Assurance 质量保证

QAU Quality Assurance Unit 质量保证部门

QC Quality Control 质量控制

QWP Quality Working Party 质量工作组

RA Regulatory Authorities 监督管理部门

REV Revision 修订

SA Site Assessment 现场评估

SAE Serious Adverse Event 严重不良事件

SAP Statistical Analysis Plan 统计分析计划

SAR Serious Adverse Reaction 严重不良反应

SD Source Data/Document 原始数据/文件

SD Subject Diary 受试者日记

SDV Source Data Verification 原始数据核准

SEL Subject Enrollment Log 受试者入选表

SFDA State Food and Drug Administration 国家食品药品监督管理局SI Sponsor-Investigator 申办研究者

SI Sub-investigator 助理研究者

SIC Subject Identification Code 受试者识别代码

SOP Standard Operating Procedure 标准操作规程

SPL Study Personnel List 研究人员名单

SSL Subject Screening Log 受试者筛选表

T&R Test and Reference Product 受试和参比试剂

T-BIL Total Bilirubin 总胆红素

T-CHO Total Cholesterol 总胆固醇

TG Thromboglobulin 血小板球蛋白

Tmax Time of maximum concentration 达峰时间

TP Total proteinum 总蛋白

UAE Unexpected Adverse Event 预料外不良事件

WHO World Health Organization 世界卫生组织

WHO- WHO International Conference WHO 国际药品管理当局会议ICDR A of Drug Regulatory Authorities

Aberrant result 异常结果

Absorption phase 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

Audit Report 稽查报告

Audit 稽查

Auditor 稽查员

Analytical run/batch:分析批

Benefit 获益

Bias 偏性,偏倚

Bioequivalence 生物等效

Biosimilar /Follow-on biologics 生物仿制药

Blank Control 空白对照

Blind codes 编制盲底

Blind review 盲态检查/盲态审核

Blinding method 盲法

Blinding/masking 盲法/设盲

Block size 每段的长度

Block 层/分段

BCS 生物药剂学分类系统

Carryover effect 延滞效应

Case history 病历

Clinical equivalence 临床等效性

Clinical study 临床研究

Clinical Trial Report 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

Confidence level 置信水平

Consistency test 一致性检验

Contract/ agreement 协议/合同

Control group 对照组

Coordinating Committee 协调委员会

Crossover design 交叉设计

Cross-over Study 交叉研究

Cure 痊愈

Data management 数据管理

Descriptive statistical analysis 描述性统计分析

Dichotomies 二分类

Dispense 分布

Diviation 偏差

Documentation 记录/文件

Dosage forms 剂型

Dose dumping 剂量倾卸(药物迅速释放入血而达到危险浓度)Dose-reaction relation 剂量-反应关系

Double blinding 双盲

Double dummy 双模

Drop out 脱落

Effectiveness 疗效

Elimination phase 消除相

Emergency envelope 应急信件Enantiomers 对映体

End point 终点

Endpoint criteria/ measurement 终点指标Enterohepatic recycling 肠肝循环Essential Documentation 必需文件Ethical 伦理的

Ethics committee 伦理委员会

Evaluate 评估

Exclusion Criteria 排除标准

Excretion 排泄

Expedite 促进

Extrapolated 外推的

Essentially similar product:基本相似药物Factorial design 析因设计

Failure 无效,失败

Finacing 财务,资金

Final point 终点

First pass metabolism 首过代谢

Fixed-dose procedure 固定剂量法

Full analysis set 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

Generic drug 通用名药

Gene mutation 基因突变

Genotoxicity tests 生殖毒性试验

Global assessment variable 全局评价变量Group sequential design 成组序贯设计Hypothesis test 假设检验

Highly permeable:高渗透性

Highly soluble:高溶解度

Highly variable drug:高变异性药物Highly:Variable Drug 高变异性药物HVDP:高变异药物制剂

Identification 鉴别,身份证Improvement 好转

In vitro 体外

In vivo 体内

Inclusion Criteria 入选表准

Information Gathering 信息收集

Initial Meeting 启动会议

Inspection 检察/视察

Institution Inspection 机构检察Instruction 指令,说明

Integrity 完整,正直

Intercurrent 中间发生的,间发的

Inter-individual variability 个体间变异性Interim analysis 期中分析Investigational Product 试验药物Investigator 研究者

Involve 引起,包括

IR 红外吸收光谱

Innovator Product:原创药

Ka 吸收速率常

LC-MS 液相色谱-质谱联用

logarithmic transformation 对数转换

Logic check 逻辑检查

Lost of follow up 失访

Mask 面具,掩饰

Matched pair 匹配配对

Metabolism 代谢

Missing value 缺失值

Mixed effect model 混合效应模式

Modified release products 改良释放剂型Monitor 监查员

Monitoring Plan 监察计划

Monitoring Report 监察报告

MS-MS 质谱-质谱联用

Multi-center Trial 多中心试验

Negative 阴性,否定的

Non-clinical Study 非临床研究

Non-inferiority 非劣效性

Non-Linear Pharmacokinetics 非线性药代动力学Non-parametric statistics 非参数统计方法NTID:窄治疗指数制剂

Obedience 依从性

Open-blinding 非盲

Open-label 非盲

Original Medical Record 原始医疗记录Outcome Assessment 结果评价

Outcome measurement 结果指标

Outlier 离群值

OIP 经口服吸收药物

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Permeability 渗透性

Pharmacodynamic characteristics 药效学特征Pharmacokinetic characteristics 药代学特征Placebo Control 安慰剂对照

Placebo 安慰剂

Polytomies 多分类

Post-dosing postures 给药后坐姿

Potential 潜在的

Power 检验效能

Precision 精密度

Preclinical Study 临床前研究

Precursor 母体前体

Premature 过早的,早发

Primary endpoint 主要终点

Primary variable 主要变量

Prodrug 药物前体

Protocol amendment 方案补正

Protocol Amendments 修正案

Protocol 试验方案

Quality Control Sample:质控样品

Rapidly dissolving:快速溶出

Racemates 外消旋物

Randomization 随机/随机化

Range check 范围检

Rating scale 量表

Recruit 招募,新会员

Replication 可重复

Retrieval 取回,补修

Revise 修正

Risk 风险

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 样本量、样本大小

Sampling schedules 采血计划

Scale of ordered categorical ratings 有序分类指标Secondary variable 次要变量

Sequence 试验次序

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

Site audit 试验机构稽查

Solubility 溶解度

Specificity 特异性

Specify 叙述,说明

Sponsor-investigator 申办研究者

Standard curve 标准曲线

Statistical model 统计模型

Statistical tables 统计分析表

Steady state 稳态

Storage 储存

Stratified 分层

Study Audit 研究稽查

Study Site 研究中心

Subgroup 亚组

Sub-investigator 助理研究者

Subject Enrollment Log 受试者入选表

Subject Enrollment 受试者入选

Subject Identification Code List 受试者识别代码表

Subject Recruitment 受试者招募

Subject Screening Log 受试者筛选表

Subject 受试者

Submit 交付,委托

Superiority 检验

Supplemental 增补的

Supra-bioavailability 超生物利用度(试验药的生物利用度大于对照药)Survival analysis 生存分析

System Audit 系统稽查

SmPC:药品说明书

Standard Sample:标准样品

Target variable 目标变量

Treatment group 试验组

Trial error 试验误差

Trial Initial Meeting 试验启动会议

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

Therapeutic equivalence:治疗等效性

Un-blinding 破盲/揭盲

Verify 查证、核实

Visual analogy scale 直观类比打分法

Vulnerable subject 弱势受试者

Wash-out Period 洗脱期

Well-being 福利,健康

Withdraw 撤回,取消

药代动力学参数

Ae(0-t):给药到t时尿中排泄的累计原形药。

AUC: 血浆浓度-时间曲线下面积

AUCτ:

AUC(0-t):从给药到时间t时血药浓度曲线下面积

AUC(0-∞):从给药到所有原形药物全部被消除的血药浓度曲线下面积

AUC(0- ):达稳态时一个剂量间隔期间的血药浓度曲线下面积

AUC(0-72h):从开始给药到给药后72小时血药浓度曲线下面积

AUC0-:血药浓度-时间曲线从时间0到无穷远的曲线下面积

AUC0-tau:血药浓度-时间曲线在稳态时,从时间0到T的曲线下面积( T为给药间隔时间)

AUCss:稳态药时曲线下面积

C max:最大血药浓度

C max,ss:最大稳态血药浓度

C min,ss:最小稳态血药浓度

Cmin:给药间隔末的浓度

Ct:最后一次可测量到的药物浓度

Cav:平均稳态血药浓度Cav=AUCss/τ

残留面积:外推面积((AUC(0-∞) - AUC(0-t))/ AUC(0-∞))R max:最大尿排泄速率

t max:达峰时间

t max,ss:最大稳态血药浓度达峰时间

t1/2:血药浓度半衰期(Elimination half life)

τ:给药时间间隔

F:相对生物利用度:

λz:终末速率常数

Z:终末或消除速率常数

CL:clearance清除率CL h 肝清除率CL r肾清除率CI:confidence interval 可信区间

DF:波动系数

CV:个体内变异系数

[U,L]=exp[±k*s WR]

S WR:为参比制剂C max值经对数转换后的个体内标准差U:指可接受的上限值

L:为可接受的下限值

θ:个体差别

f2-test / f2:相似因子(体外溶出试验)

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