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1、FDA Glossary Compiled by: Yaw-Tsong LeeLast updated: November 21, 2010Top 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 Bro
2、ker 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 Found
3、ation 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 Rheumat
4、ology)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 polype
5、ptide containing 140 amino acids干扰素微克 1baction 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adalim
6、umab (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 ther
7、apy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a
8、dverse 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
9、 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
10、黄曲霉素; 黄曲霉毒素african sleeping sickness非洲昏睡病; 非洲锥虫病AFSSAPS = Agence Franaise de Scurit Sanitaire des Produits de Sant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
11、 companys applications are not reliable, the agency will not perform substantive review of any of the companys 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
12、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 fail
13、ure 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
14、 found on X-rays), such as rickets, osteomalacia, bone tumors, Pagets 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
15、 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 Gehrigs 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Alzheimers Disease老年痴呆症;阿尔茨海默氏病amino acid seque
16、nce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 l
17、east 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
18、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 resista
19、nce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-治疗AORN = Association of Perioperative Registered Nurses美国围手术注册护士协会aortic dis
20、ease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a
21、pproval批准approved drugs 已批准药物approximate lethal dose = ALD 近似致死剂量aprotinin抑肽酶AQSIQ = Chinas 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
22、 = 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 On
23、cology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
24、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 reportsassay constancy CA检验恒定性assay sensitiviy AS检验灵敏度assistant investigator = AI助理
25、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 f
26、or 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 drugATR = att
27、enuated 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,
28、 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Aventi
29、s 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 Simu
30、lect)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 eve
31、n 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
32、香酸Best Pharmaceuticals for Children Act 2002最好的儿童医药品法案beta-blocker-受体阻滞剂Bextra (valdecoxib)伐地考昔(镇痛类药物)BfARM = Bundesinstitut fr 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bilirub
33、in 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 compatibl
34、e 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 encapsul
35、ated 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 o
36、r 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 bodys response to infection and disease. The body naturally prod
37、uces 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 progre
38、ss 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
39、 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 ana
40、lysis 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
41、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 notific
42、ation 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BS
43、E = 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
44、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) syst
45、em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 patients 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 MonitorCarelink 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
