FDA术语词汇全汇总.docx

1、FDA术语词汇全汇总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/absorpt

2、ion 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 converti

3、ng 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 = Automated Commercial System自动商业系统ACTH = adrenocorticotrop

4、ic hormone促肾上腺皮质激素Actimmune (Interferon gamma-1 b)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 fra

5、ctures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auxil

6、iary;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 reac

7、tion = 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aflatoxin 黄曲霉素; 黄曲霉毒素african sleeping sickness非洲昏睡病; 非洲锥虫病AFSSAP

8、S = 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 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 丙氨酸氨基转移酶ALAR

9、P 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 = ALP 碱性磷酸酶allergenicity致敏性allergic shock过敏性休克allograft transplantation同种异体移植ALOP = Appro

10、priate 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 sequence氨基酸序列aminoglycoside antibiotics氨基糖苷类抗生素amphetami

11、nes安菲他明amyotrophic lateral sclerosis = ALS肌萎缩侧索硬化analysis of covariance (ANCOVA)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 r

12、esistance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aort

13、ic 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

14、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 = 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

15、积ARGNB = antibiotic-resistant gram-negative bacilli 耐药革兰阴性杆菌ARM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

16、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 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助理研究者assurance

17、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接受治疗分析atopic dermatitis = AD异位性皮炎atorvastatin阿伐他汀系列cholesterol-

18、lowering drugATR = 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 transplantati

19、on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)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 = Ca

20、v 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（ce

21、rivastatin 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苯重氮基盐; 苯二氮卓类抗焦虑药benzoic acid安息香酸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 Arznei

22、mittel 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)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bioequi

23、valence; bioequivalent (i.e., performs in the same manner as the innovator drug生物等效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

24、产品biosimilar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

25、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botul

26、inum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 Cust

27、oms 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camp

28、ylobacter 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 resynch

29、ronization 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分类变量catheters导管cathlab bypass导管室搭桥Cav平均浓度CBE supplement “Changes Being Effected” supplement (FDA)“正在进行修改”补充申请CBP (U.S.