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1、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
2、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 (AT
3、M) 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 refl
4、ux 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 = adrenocorticotrop
5、ic 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 Fi
6、le (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 a
7、nd 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 ex
8、cretion 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
9、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, in
10、cluding 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 sleep
11、ing 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
12、 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 aminotra
13、nsferase (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 L
14、ethal 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
15、 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 transpla
16、nted 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;
17、 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
18、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
19、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 applica
20、tion 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，ana
21、lgesics 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 Serv
22、ice 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
23、 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 b
24、acilli 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 Oncol
25、ogy 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, addit
26、ional 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 sensit
27、iviy 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
28、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
29、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、
30、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
31、 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
32、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
33、 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 t
34、o 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 Ac
35、t 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
36、 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 biol
37、ogically 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
38、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 p
39、revention, 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
40、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 biochemi
41、cal 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 descri
42、be 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
43、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
44、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
45、 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 graft
46、ing 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 = Bus
47、iness 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 Rat
48、e 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
49、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
50、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
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