A

action letter 决定通知

active comparator 活性药物对照组

active control = AC 阳性对照，活性对照

active ingredient 有效成分

Active Substance Master File (ASMF) 欧洲药物主文件

acute myocardial infarction 急性心肌梗死

acute tibial fractures 急性胫骨骨折

adalimumab (Humira) 阿达木单抗

adaptive design 自适应设计

adaptive randomization 自适应随机

ADE = adverse drug event 药物不良事件

Adenoviral Vectors 腺病毒载体

adequate and well-controlled studies 充分严格的对照研究

ADHD = Attention-deficit hyperactivity disorder

注意力缺陷多动障碍; 注意力不足过动症; 多动症adhesion barrier product 防黏著产品

adjuvant 助剂; 佐剂auxiliary;

adjuvant therapy 佐药疗法，辅助疗法

ADL = activities of daily living 日常生活活动能力

ADME = absorption, distribution, metabolism, and excretion

(药物)吸收、分配、代谢和排除

ADR = adverse drug reaction 药物不良反应

adrenal cortex 肾上腺皮质

adrenal cortical hormone 肾上腺皮质激素

adrenal gland 肾上腺

adrenaline 肾上腺素

adulterated devices 掺假器械

adverse drug reaction = ADR药物不良反应

adverse effect 副作用

adverse event = AE 不良事件

adverse medical events 不良医学事件

adverse reaction (adverse event) 药物不良反应

advisory 提醒

advocacy and support groups 倡导和支持团体

AE = adverse event 不良事件

AERS = Adverse Event Reporting System 不良事件报告系统

B

BIMO Bioresearch Monitoring Program 生物研究监测

bioavailability (F) 生物利用度

biochemical drugs 生化药品

biocides 生物杀灭剂; 杀生物剂

biocompatibility 生物相容性biodegradable 生物分解

bio-engineered, transgenic food 转基因食物

bioequivalence; bioequivalent 生物等效应

biofilm 细菌薄膜, 生物膜

biologic 生物制品

biological response modifiers BRM 生物应答调节剂

biological therapeutic agents 生物治疗药剂

biomarker 生物标志物

biometrics 生物统计; 生物识别技术

bion stimulator 生物体刺激器

bionic knee 仿生膝关节

biopharma: biopharmaceutical products 生物药物产品

bipolar 双相燥郁症

birth defect 出生缺陷, 新生儿缺陷, 先天缺陷BLA = biologic license application 生物制品许可申请

blank control 空白对照

blend uniformity analysis 混合均匀度分析

blind 盲法

blind codes 编制盲底

blind review 盲态审核

blinding method 盲法

blinding/ masking 盲法，设盲

blister packaging 泡罩包装; 水泡眼

block 分段;层

block size 每段的长度

blocked randomization 区组随机

C

case history 病历

case record form = CRF病例报告表/病例记录表

case report form 病例报告表

cash curve 现金曲线

cash trap 现金陷阱; 现金套牢categorical variable 分类变量

CLIA Clinical Laboratory Improvement Amendments

临床实验室改进修订案

clinical (human) data 临床数据

clinical endpoint临床终点

clinical equivalence 临床等效应

clinical hold 临床试验暂停通知

clinical investigator 临床研究者

Clinical Pharmacists 临床药师

Clinical Research Coordinator = CRC临床研究协调者

clinical study 临床研究

Clinical Study Application = CSA临床研究申请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 Trial Report = CTR临床试验报告

clinically significant results 有临床意义

cohort 队列

cohort studies 队列研究

co-investigator = CI合作研究者

comparison 对照

Compassionate Use 体恤使用

competitive labeling 优越标签

Complementary And Alternative Therapy 补充性和非传统治疗Complete response 完全有效

compliance 遵守；对遵守法规情况的监管composite variable 复合变量

Compression Test 压缩试验

computer-assisted trial design= CATD计算机辅助试验设计

Con Meds = concomitant medications 联合用药

confidence interval 可信区间

confidence level 置信水平

Confidentiality Regarding Trial Participants 为试验参与者保密

control对照

control group 对照组

controlled clinical trials 临床对照实验

Controlled Trials 对照试验

Critical Path 关键路径

CRM = continual reassessment method 连续重新评估方法crossover design 交叉设计

cross-over study 交叉研究

crossover therapy 交叉治疗

CRF = case report form 病例报告表

dosage form 剂型

dosage regimen 给药方案

dose-ranging study 剂量范围研究

dose-reaction relation 剂量－反应关系

dose-related adverse reactions 剂量相关的不良反应

double blinding 双盲

double dummy 双模拟

double dummy 双模拟

double dummy technique 双盲双模拟技术

double-blind study 双盲研究

Double-Masked Study 双盲研究DRGs = Diagnosis Related Group System 疾病诊断相关分组

drop out 脱落

drop test 落震试验;跌落试验

drug eluting coronary stents 药物洗脱支架

drug product 药物产品

drug substance 原料药

drug-drug interaction56 药物-药物相互作用

drug-food interaction 药物-食物的相互作用

EEPS = Electronic Entry Processing System 电子录入处理系统

effectiveness 疗效

efficacy 有效性测定

efficacy (Of a drug or treatment) 药效；药品疗效

E

EMEA = European Medical Evaluation Agency; European Agency for the Evaluation of Medicinal Products; European Medicines Agency 药物评价机构; 欧洲医药品管理局

emergency envelope 应急信件

Empiric Bayesian Multiple Gamma-Poisson Shrinker

经验性贝氏法（伽玛泊松分布缩检法）empirical 经验性

endpoint 终点

endpoint criteria 终点指标

factorial design 析因设计

factorial trial 析因试验

failure 无效，失败

Fair Packaging and Labeling Act (1966) 公平包装和标签法

False Claims Act 防制不实请求法

false therapeutic claims 错误的疗效声明

full analysis set 全分析集

full factorial design 全因子试验法

I

inclusion criteria 入选标准

inclusion/exclusion criteria 入选/排除标准

incremental exposure 食品中递增摄入量

incubation period/latency period 潜伏期

IND = Investigational New Drug 临床研究新药

INDA = investigational new drug application NDA前申报阶段

indemnity insurance 赔偿保险

Independent Data Monitoring = IDM数据监察

Independent Data Monitoring Committee = IDMC

数据监察委员会

independent ethics committee = IEC 伦理委员会

indications 适应症

investigational new drug = IND 临床研究新药

investigational product 试验药物investigator 调研人员

investigator's brochure = IB 研究者手册

M

masked 设盲

mean absorption time = MAT(药物在体内的)平均吸收时间mean disintegration time = MDIT(药物在体内的)平均崩解时间Mean Dissolution Time = MDT (药物在体内的)平均释放时间Mean Residence Time = MRT(药物在体内的)平均滞留时间medical governance 医药治理

Medicare 老年医疗保险制度；联邦老年医保medication guides (for patients) 用药指南

Medicines Control Agency = MCA英国药品监督局

Misbranding 错误标签; 冒牌

Miscoding 编码错误

missing value 缺失值

mixed effect model 混合效应模式

MLD = minimal lethal dose 最小致死剂量

MoA = Mechanism of Action 作用机制;作用机理

monitor 监查员

monitoring plan监查计划

monitoring report 监查报告

MR = moderate response 好转

MRA = Agreement on Mutual Recognition 相互承认协定

MTD = maximal tolerance dose 最大耐受剂量

multicenter trial 多中心试验

multi-drug resistance 多药物抗药性

multiple arm trials 多治疗组的试验

mutual recognition procedure (EU) 相互承认程序

O

OS = Overall survival 总生存率

P

parallel group design 平行组设计

parameter estimation 参数估计

parametric release 参数放行

parametric statistics 参数统计方法

patient file 病人档案

patient global; pt global 病人总体评价

patient history 病历

per protocol ( PP) analysis 符合方案分析

PFS = progression-free survival 无疾病进展存活率

PGE = patient global evaluation 病人总体评价

PHA = preliminary hazards analysis 预先危险分析

pharmaceutical equivalence 药剂等效性

pharmaceutics药剂学pharmacodynamics=PD 药物效应动力学; 简称药效学pharmacoepidemiology 药物流行病学

pharmacokinetics = PK 药代动力学; 简称药动学

pharmacology 药理学

Pharmacovigilance105 药物警戒

pharmacy 配药学

PharMetrics claims database 索赔数据库

PhRMA = Pharmaceutical Research and Manufacturers of America

美国药物研究与生产商协会

PIC=Pharmaceutical Inspection Convention 药品检查协定

PIC/S Pharmaceutical Inspection Cooperation Scheme 药物检查合作计划

pipeline assets 开发中产品

PK = pharmacokinetics 药物代谢动力学; 药动学，药代动力学placebo 安慰剂

placebo control 安慰剂对照

placebo controlled study 安慰剂对照研究

placebo effect 安慰剂效应

PMA = premarket approval 上市前许可; 销售前批准

PMCs = post marketing commitments 承诺药品上市后的继续研究

PMDRA = Post Marketing Drug Risk Assessment 上市后药品风险评估(办公室) PMHx = Past Medical History 既往病史

PMN = Premarket Notification 销售前通知

PMS = Premenstrual syndrome 经前综合症

POC (Proof-of-concept) Clinical Trials 概念证明

POC = point-of-care testing 床旁分析

polytomies 多分类

pooled analysis = PA 荟萃分析

postmarket surveillance 上市后监督

post-marketing surveillance; postmarket safety surveillance 销售（上市）后监督power 把握度; 检验效能

Pp = Process Performance 工序绩效

Ppk = Process Performance Index 工序绩效指数

precautions 慎用；注意事项

precision 精密度

preclinical (animal) data 临床前(动物实验)数据

preclinical study 临床前研究

predicate device = legally marketed device that is not subject to Premarket Approval (PMA)

和已合法在市场上销售的且不需要做PMA“销售前批准”的Pre-market Approval (Application) = PMA上市前许可（申请）premarket notification 上市前通知

pre-marketing surveillance 销售（上市）前监督

preparing and submitting 起草和申报

prescription drug 处方药

preservation 保藏

prevalence 患病率

prevention trials预防试验

primary (coronary) event 原位病变

primary endpoint 主要终点

primary mode of action = PMOA 首要作用模式

primary variable 主要变量

principal investigator = PI主要研究者

Principles of Qualification 确认（验证）原则

process controls 工艺控制

process validation 工艺验证

product codes 产品的号码

product differentiation 产品差异化，产品特色化product license = PL 产品许可证

product life cycle (PLC) 产品生命周期

prognosis 预后

progression-free survival = PFS 无进展生存

progressive Disease PD 病情进展

proof of principle study 原理循证研究

propensity score 倾向性评分

protocol 试验方案; 方案

protocol amendment 方案补正

prototype design 原型设计

protozoa 原生动物门

proven acceptable Range = PAR 确定可接受范围

PTC = Product Technical Complaints 药品技术投诉

Q

qualification system for licensed pharmacist 执业药师资格准入制度qualified health claims 有保留的健康宣称

Qualified Person = QP 受权人

quality assurance = QA质量保证

quality assurance unit = QAU质量保证部门

quality control = QC 质量控制

quality management systems 质量管理体系

quality of life trials or supportive care trials 生存质量试验

quality risk management = QRM 质量风险管理

quantitative risk assessment 量化风险评估

R

randomization 随机化

randomized trial 随机化试验

randomized, double blinded clinical trial 随机双盲对照研究

range check 范围检查

rating scale 量表

RCT = randomized clinical trials 随机临床试验

RCT = randomized controlled trial 随机对照试验RDE: remote data entry 远距数据输入

ready-to-eat foods 即食食品

reagents 试剂

recall 召回; 强制回收

RECIST = Response Evaluation Criteria in Solid Tumors 实体瘤的疗效评价标准reconditioning 整改; 货物重整理；货物重包装

recycled plastics 可循环利用塑料制品

reference product 参比制剂

reference samples 标准样品

regulatory methodology 质量管理方法

regulatory methods validation 管理用分析方法的验证（FDA对NDA提供的方法进行验证）regulatory specification 质量管理规格标准（NDA提供）

rejection 排异

remote monitoring system 远程监测系统; 远程监控

REMS = Risk Evaluation and Mitigation Strategies 风险评估和减缓战略

risk 受害

risk assessment (risk analysis + risk evaluation) 风险评估，论证

risk classification 风险分类;

Risk Communications Advisory Committee 风险交流咨询委员会

risk evaluation (part of risk assessment) 风险评价

risk/ benefit analysis 风险-获益分析

risk-benefit ratio 效益/风险比

route of administration 给药途径

royalties 专利使用费

RPN = Risk Priority Number 风险优先指数

RR = Response rate 缓解率

RSD = (intra-day and inter-day) relative standard deviations (日内和日间) 相对标准差S

safety advisory 安全建议

safety evaluation 安全性评价

safety evaluators 安全性评估人员

safety set 安全性评价的数据集

screening trials 筛选性试验

SD = standard deviation 标准(偏)差

SE = substantial equivalence 实质上的等同

Seal Strength Test 密封强度试验

sequence 试验次序

SFDA 129= State Food And Drug Administration 国家食品药品监督管理局

SG & A= Sales, General and Administration 销售、管理和一般费用

shaft 传动轴

SHEA = Society for Healthcare Epidemiology of America 美国医院流行病学学会

sheaths 护套

shelf life 保存期限; 保质期

SIC codes = Standard Industrial Classification codes 标准产业分类代码side effects 副作用

significance level 显著性水平

Significant Risk (SR) 显著的危险性

simple randomization 简单随机

simulation model 仿真模型

single blinding单盲

single-blind study 单盲研究

single-masked study 单盲研究

site assessment = SA现场评估

site audit 试验机构稽查

SMDA = Safe Medical Devices Act of 1990 1990年安全医疗器械法

SMF = Site Master File 生产场所主文件

sNDA = supplemental NDA 疗效补充新药上市申请

sponsor-investigator = SI 申办研究者

spontaneous reports; voluntary reports 药品不良反应自愿报告

SPS = Agreement on the Application Of Sanitary and Phytosanitary Measures

卫生与植物卫生措施实施协议;简称SPS协议SSI = surgical site infection 手术部位感染

SSOPs = Sanitation Standard Operating Procedures 卫生标准操作程序standard curve 标准曲线

standard deviation 标准偏差

standard drug 标准药物

standard operating procedure = SOP 标准操作规程

standard treatment 标准治疗

Standards Of Care131 医护标准

State Food and Drug Administration = SFDA国家食品药品监督管理局statistic 统计量

statistical analysis plan = SAP 统计分析计划

statistical model 统计模型

statistical significance 统计学意义

statistical tables 统计分析表

Statisticians in the Pharmaceutical Industry = PSI制药业统计学家协会steady-state Area Under the Curve = AUCss

稳态药时曲线下面积/稳态血药浓度－时间曲线下面积stratified 分层

study audit 研究稽查

study endpoint 研究终点

Study Personnel List = SPL研究人员名单

study site研究中心

study type 研究类型

subchronic toxicity studies 亚慢性毒性研究

subgroup 亚组

sub-investigator 助理研究者

subject 受试者subject diary = SD 受试者日记

subject enrollment 受试者入选

subject enrollment log = SEL受试者入选表

Subject Identification Code List = SIC受试者识别代码表

subject recruitment 受试者招募

subject screening log = SSL受试者筛选表

submission 申报；递交

subspecialties, internal medicine 亚专科,内科

substantial equivalence to legally marketed (predicate) device 和已合法在市场上销售的且不需要做PMA“销售前批准”的相似产品有实质上的等同

T

train-the-trainer program 培训者培训计划

treatment group 试验组

treatment IND 治疗性试验性新药申请

treatment trials 治疗性试验

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

TRICARE 医疗系统

triple blinding 三盲

two one-side test 双单侧检验

UAE = unexpected adverse event 预料外不良事件

unblinding 破盲;揭盲

under reporting bias 少报偏差

unexplained syncope 不明原因晕厥

unresectable 不能手术切除

variability 变异

variable 变量

WHO International Collaborating Center for Drug Monitoring

(世界卫生组织)国际药物监测合作中心

WHO International Conference of Drug Regulatory Authorities= WHO-ICDRA

WHO国际药品管理当局会议

WHO Programme for International Drug Monitoring = PIDM

WHO 国际药物监测合作计划下载本文