FDA医药英文词汇.doc

FDA Glossary
Compiled by: Yaw-Tsong Lee
Last updated: November 21, 2010
[Top] [Laws & Regulations] [FDA Organization] [SFDA国食药监]
食品和药物管理局局长玛格丽特•汉堡(Margaret Hamburg)
2-(4-hydroxyphenyl) acetamide
2 -（ 4 -羟苯基）乙酰胺
AAA = abdominal aortic aneurysm
腹主动脉瘤
ABCs = airways，breathing，circulation
气道、呼吸、循环
ABI/ACS = Automated Broker Interface of the Automated Commercial System
自动商业系统下的自动经纪人界面(CBP的自动商业系统)
absorbable collagen sponge
吸收性胶原海绵
absorption rate constant/absorption rate coefficient Ka　
吸收速率常数/吸收速率系数
abstinence symptoms
戒断症状
accelerated approval
加速批准
access to medicine (ATM)
有药品可使用
ACCF = American College of Cardiology Foundation
美国心脏病学会基金会
accredited school
立案学校
accuracy
准确度
Accutane, a brand of isotretinoin
异维生素A酸; 异维A酸;异维甲酸; 保肤灵
ACE inhibitors = angiotensin converting enzyme inhibitors = ACEI
血管紧张素转化酶抑制剂
acetaminophen
扑热息痛; 对乙酰(xian)氨基酚
acid reflux
胃酸逆流
acidified food
酸化食品
ACR-20 improvement criteria (American College of Rheumatology)
美国风湿病学会类风湿关节炎改善的基本定义要求触痛关节数减少≥20% 肿胀关节数减少≥20% 加上以下五条中三条好转≥20%
acrylamide
丙烯酰胺
ACS of the Bureau of Customs and Border Protection (CBP)
= Automated Commercial System
自动商业系统
ACTH = adrenocorticotropic hormone
促肾上腺皮质激素
Actimmune (Interferon gamma-1 b) a biologic response modifier, is a single-chain polypeptide containing 140 amino acids

干扰素微克— 1b
action letter
决定通知
active comparator
活性对照药物；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
Actos (pioglitazone)
艾可拓(匹格列酮) (日本武田制药公司Takeda的糖尿病药物)
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
药物的吸收、分布、代谢和排泄
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) An unwanted effect caused by the administration of drugs. Onset may be sudden or develop over time

药物不良反应
advisory
提醒
advocacy and support groups Organizations and groups that actively support participants and their families with valuable resources, including self-empowerment and survival tools.　　

倡导和支持团体
AE = adverse event A negative experience encountered by an individual during the course of a clinical trial that is associated with the drug.

不良事件
AERS = Adverse Event Reporting System
不良事件报告系统
aflatoxin
黄曲霉素; 黄曲霉毒素
african sleeping sickness
非洲昏睡病; 非洲锥虫病
AFSSAPS = Agence Française de Sécurité Sanitaire des Produits de Santé
法国卫生安全和健康产品委员会; 法国医疗产品安全局
after effect
后遗效应
agency
审理部门（指FDA）
AHA = American Heart Association
美国心脏病协会
AIP = Application Integrity Policy The basic premise of AIP is: If FDA determines that a company’s applications are not reliable, the agency will not perform substantive review of any of the company’s applications until confidence in the data is restored.
also Fraud Policy
防伪政策
air embolism
气体栓塞
air handling
空气处理
air lock
阻隔室
alanine aminotransferase = ALT An alanine aminotransferase (ALT) test measures the amount of this enzyme in the blood. ALT is measured to see if the liver is damaged or diseased.

丙氨酸氨基转移酶
ALARP region (as low as reasonably practicable)
尽合理可行程度的低
Alb = albumin
白蛋白
Alcohol and Tobacco Tax and Trade Bureau TTB
烟酒税务和贸易局
ALD = Approximate Lethal Dose
近似致死剂量
ALF = acute liver failure
急性肝功能衰竭
alkaline phosphatase to check for liver disease or damage to the liver. Symptoms of liver disease can include jaundice, belly pain, nausea, and vomiting. An ALP test may also be used to check the liver when medicines that can damage the liver are taken or to check bone problems (sometimes found on X-rays), such as rickets, osteomalacia, bone tumors, Paget's disease, or too much of the hormone that controls bone growth (parathyroid hormone).
= ALP　
碱性磷酸酶
allergenicity
致敏性
allergic shock
过敏性休克
allograft An allograft is a transplanted organ or tissue from a genetically non-identical member of the same species
transplantation
同种异体移植
ALOP = Appropriate Level of Protection
适当的保护水平
ALP = Alkaline phosphatase
碱性磷酸酶
alpha spending function    
消耗函数
ALS = amyotrophic lateral sclerosis; Lou Gehrig’s Disease
肌萎缩性脊髓侧索硬化; 渐冻症
ALT = alanine aminotransferase
丙氨酸氨基转换酶
Alzheimer’s Disease
老年痴呆症;阿尔茨海默氏病
amino acid sequence
氨基酸序列
aminoglycoside antibiotics
氨基糖苷类抗生素
amphetamines
安菲他明
amyotrophic lateral sclerosis = ALS
肌萎缩侧索硬化
analysis of covariance (ANCOVA) is a general linear model with a continuous outcome variable (quantitative) and two or more predictor variables where at least one is continuous (quantitative) and at least one is categorical (qualitative). ANCOVA is a merger of ANOVA and regression for continuous variables. ANCOVA tests whether certain factors have an effect on the outcome variable after removing the variance for which quantitative predictors (covariates) account. The inclusion of covariates can increase statistical power because it accounts for some of the variability

协变量分析
analysis sets    
统计分析的数据集
analyte
待测物
anaphylaxis
过敏性反应
ANDA = abbreviated new drug application
简化新药申请
angina pectoris
心绞痛
angioplasty balloons
血管修复气囊
animal trial
动物试验
anotia
无耳;又称“无耳畸形”
antibiotic prophylaxis
预防性抗生素使用
antibiotic resistance
抗生素抗性
anti-inflammatory agents
抗炎药
anti-metabolites
干扰代谢药物
antimicrobial resistance
耐药性
anti-nutrients
抗营养素
antipyretic，analgesics and anti-inflammatory drugs
解热镇痛抗炎药
anti-TNF agent; TNF blocker drugs
抗肿瘤坏死因子抑制剂
anti-TNF therapy
抗TNF-α治疗
AORN = Association of Perioperative Registered Nurses
美国围手术注册护士协会
aortic disease
主动脉疾病
aortic stenosis
主动脉瓣狭窄
APEC
亚太经济合作组织
APHIS = Animal and Plant Health Inspection Service
动植物卫生检验局
APIC = Association of Professionals of Infection Control and Epidemiology
美国感染控制和流行病专业协会
APIs = active pharmaceutical ingredients
原料药
aplastic anemia
再生障碍性贫血
Appropriate Level of Protection (ALOP)
适当的保护水平
approval
批准
approved drugs
已批准药物
approximate lethal dose = ALD　
近似致死剂量
aprotinin
抑肽酶
AQSIQ = China's General Administration for Quality Supervision, Inspection and Quarantine
国家质量监督检验检疫总局; 质检总局
archival copy
存档用副本
Area Under the Curve = AUC; area under the plasma concentration-time curve
药时曲线下面积/血药浓度-时间曲线下面积
ARGNB = antibiotic-resistant gram-negative bacilli
耐药革兰阴性杆菌
ARM Any of the treatment groups in a randomized trial.　　

组
arrhythmia
心律不齐
arsenicals = arsenic compounds
砷化合物
artificial discs
人造脊椎
artificial heart valve
人工心脏瓣膜
artificial pancreas
人工胰脏
AS = ankylosing spondylitis
强直性脊柱炎
ASCO = American Society of Clinical Oncology
美国临床肿瘤学会
ASD = atrial septal defect
房间隔缺损
aseptic packaging
无菌包装
Asian Harmonization Working Party = AHWP
医疗器械法规亚洲协调会
aspartate aminotransferase = AST Low levels of AST are normally found in the blood. When body tissue or an organ such as the heart or liver is diseased or damaged, additional AST is released into the bloodstream. The amount of AST in the blood is directly related to the extent of the tissue damage.

天门冬氨酸氨基转移酶
aspergillin
曲霉菌素
aspergillus flavus
黄曲霉
aspergillus ochraceus
赫曲霉
ASR = alternative summary reports

assay constancy CA
检验恒定性
assay sensitiviy AS
检验灵敏度
assistant investigator = AI
助理研究者
assurance A renewable permit granted by the federal government to an institution or research center to conduct clinical trials.

临床试验许可
AST = antimicrobial susceptibility test
药敏试验 = 抗菌药物敏感性试验
AST = aspartate aminotransferase
天门冬酸氨基转换酶
ASTM International (ASTM), originally known as the American Society for Testing and Materials
美国材料与试验协会
AstraZeneca
阿斯利康
as-treated analysis in an "as treated" (or "observed data") analysis only those patients still taking the assigned treatment are analyzed; those who drop out are "censored."

接受治疗分析
atopic dermatitis = AD
异位性皮炎
atorvastatin
阿伐他汀系列cholesterol-lowering drug
ATR = attenuated total reflection
衰减全反射法
attenuated total reflection = ATR　
衰减全反射法
AUCss  = area under the plasma concentration-time curve at steady-state
稳态血药浓度－时间曲线下面积
audit 指由不直接涉及试验的人员所进行的一种系统性检查，以评价试验的实施、数据的记录和分析是否与试验方案、标准操作规程以及药物临床试验相关法规要求相符

稽查
audit or inspection    
稽查／视察
audit report
稽查报告
auditor
稽查员
autoimmune disease, AID
自身免疫病
autologous marrow stem cell transplantation
自体骨髓干细胞移植
autologous structural cells
自体结构细胞
Automated Broker Interface of the Automated Commercial System = ABI/ACS
自动商业系统下的自动经纪人界面
Automated Commercial System
自动商业系统
availability of water
有效水分
Avandia (rosiglitazone) 一种批准用于治疗2型糖尿病的药物

商品名：文迪雅；通用名：罗格列酮
Aventis Pharma
安万特医药
average concentration/average concentration value = Cav　
平均浓度
B. Cereus = Bacillus cereus
蜡状芽孢杆菌
B.atrophaeus
草芽孢杆菌黑色变种
bacilli
芽孢杆菌
Bacillus anthracis
炭疽芽胞杆菌
bacterial endospores
细菌芽孢
bacterial spore
细菌孢子
bar code
条(形)码
barbiturates
巴比妥盐
basal metabolic rate
基础代谢率
baseline
基线
basiliximab (trade name Simulect)
舒莱; 治疗肾移植排斥药
batch production
批量生产；分批生产
batch release
批放行
Baycol（cerivastatin sodium）
拜斯亭;西立伐他汀; 降血脂新药
Bayer Schering Pharma
拜耳先灵医药
BCG Boston Consulting Group
波士顿咨询公司
bench test
实验室试验
benefit
受益
benzodiazepine Benzodiazepines have also been used as a "date rape" drug because they can markedly impair and even abolish functions that normally allow a person to resist or even want to resist sexual aggression or assault

苯重氮基盐; 苯二氮卓类抗焦虑药 本类药物也称弱安定药，包括氯氮卓(利眠宁，chlordiazepoxide，商品名Librium)、地西泮(安定，diazepam，商品名valium)、硝西泮(硝基安定，nitrazepam)、氟西泮(氟安定，flurazepam)及奥沙西泮(去甲羟基安定，舒宁，oxazepam)。临床主要用于镇静、催眠及对抗癫痫

benzoic acid
安息香酸
Best Pharmaceuticals for Children Act 2002
《最好的儿童医药品法案》
beta-blocker
β-受体阻滞剂
Bextra (valdecoxib)
伐地考昔(镇痛类药物)
BfARM = Bundesinstitut für Arzneimittel und Medizinprodukte
德国联邦药品和医疗器械管理局
BHC = Bayer HealthCare
拜耳医药保健有限公司
bias 指在设计临床试验方案、执行临床试验、分析评价临床试验结果时，有关影响因素所致的系统误差，致使疗效或安全性评价偏离真值。

偏倚
bicohort study
双队列研究
bilirubin
胆红素
BIMO Bioresearch Monitoring Program
生物研究监测
bioavailability (F) expression of how much drug reaches the circulation (known to pharmacologists as the central compartment) after administration

生物利用度
biochemical drugs
生化药品
biocides
生物杀灭剂; 杀生物剂
biocompatibility The property of being biologically compatible by not producing a toxic, injurious, or immunological response in living tissue

生物相容性;
biodegradable
生物分解
bio-engineered, transgenic food
转基因食物
bioequivalence; bioequivalent (i.e., performs in the same manner as the innovator drug
生物等效
biofilm A biofilm is a structured community of microorganisms encapsulated within a self-developed polymeric matrix and adherent to a living or inert surface

细菌薄膜, 生物膜
biologic A virus, therapeutic serum, toxin, antitoxin, vaccine, blood, blood component or derivative, allergenic product, or analogous product applicable to the prevention, treatment or cure of diseases or injuries of man. biological therapeutic agents that include blood and blood products, vaccines, allergenics, cell and tissue-based products, and gene therapy products

生物制品
biological response modifiers BRM Substances that stimulate the body's response to infection and disease. The body naturally produces small amounts of these substances. Scientists can produce some of them in the laboratory in large amounts for use in treating cancer, rheumatoid arthritis, and other diseases

生物应答调节剂
biological therapeutic agents
生物治疗药剂
biomarker A biochemical feature or facet that can be used to measure the progress of disease or the effects of treatment

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
biosimilar Biosimilars or Follow-on biologics are terms used to describe officially-approved subsequent versions of innovator biopharmaceutical products made by a different sponsor following patent and exclusivity expiry on the innovator product. Biosimilars are also referred to as subsequent entry biologics (SEBs) in Canada

生物类似物
bipolar
双极燥郁症
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 A randomized trial is "Blind" if the participant is not told which arm of the trial he is on. A clinical trial is "Blind" if participants are unaware on whether they are in the experimental or control arm of the study; also called masked　　

盲法
blind codes
编制盲底
blind review 在最后一份病例报告表输入数据库后，第一次揭盲之前对数据保持盲态的预分析审核，以便对统计分析计划作最后的决定。

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
blood thinner
血液稀释药
blood urea nitrogen = BUN　
尿素氮
BMP = bone morphogenetic proteins
骨形成蛋白
BMS（Bristol-Myers Squibb）
百时美施贵宝公司
BNF = biotechnology notification file
生物工程通报档案
Board Certified rheumatologist
美国国内认证的风湿病学家
Body Mass Index = BMI　
体质指数
bolus amounts
大剂量
bone grafting
骨移植
bone marrow suppression
骨髓抑制
botulinum
肉毒杆菌
botulism
肉毒中毒
boxed warnings
黑框警告
brachytherapy seeds
放射性粒子源近距离治疗
bradycardia
心动过缓
breast implants, Polyurethane-coated
乳房植入物, 聚亚安酯包囊;隆胸
bromfenac
溴酚酸
BSE = Bovine Spongiform Encephalopathy; mad cow disease
疯牛病;牛海绵状脑病
BU = Business Units
事业单位
bubble leak test
漏泄气泡测试
BUN = blood urea nitrogen
尿素氮
Bureau of Customs and Border Protection = CBP
美国海关与边境保护局
C. botulinum (proteolytic) = Clostridium botulinum
肉毒梭状芽孢杆菌（蛋白质水解型）
CABG = coronary artery bypass graft
冠状动脉旁路移植术; 冠状动脉搭桥手术
CAGR = Compound Annual Growth Rate
年均复合增长率
calcium antagonists
钙拮抗剂
calcium channel blockers = CCB
钙道阻滞剂
calibration
校准; 标定
campylobacter
弯曲杆菌
campylobacter fetus
胚胎弯曲杆菌
campylobacter Jejuni
空肠弯杆菌
cannulas
套管
CAP = corrective action plan by drug sponsor
纠正行动计划
CAPA (Corrective & Preventive Action) system
纠正与预防措施系统
Capitation A flat monthly fee that a health plan pays to a provider (doctor, hospital, lab, etc.) to take care of a patient's needs. Capitation is part of the provider-reimbursement mechanism

按人头付费
carcinogenic risk assessment, procedures for
致癌风险评估程序
cardiac arrhythmia
心律失常
Cardiac EP (electrophysiology)
心脏电力生理
cardiac resynchronization therapy
心脏再同步化治疗
Carelink Monitor
Carelink 监护
carryover effect
延滞效应
Carticel
组织工程软骨移植疗法
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