1、1FDA Glossary Compiled by: Yaw-Tsong LeeLast updated: November 21, 2010Top Laws 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)
2、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ACS1 = 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)2 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
3、分Active Substance Master File (ASMF) 欧洲药物主文件2Actos (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
4、 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
5、、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) 3 药物不良反应adviso
6、ry 提醒advocacy and support groups4 倡导和支持团体AE = adverse event 5 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 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3after effect 后遗效应agency 审理部门（指 FDA）AH
7、A = American Heart Association 美国心脏病协会 AIP = Application Integrity Policy6 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 = ALT7 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
8、 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 phosphatase8 = ALP 碱性磷酸酶allergenicity 致敏性allergic shock 过敏性休克allograft9 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 = amyotro
9、phic 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amphetamines 安菲他明amyotrophic lateral sclerosis = ALS 肌萎缩侧索硬化analysis of covariance (ANCOVA)10 协变量分析analysis se
10、ts 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4anotia 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 resistanc
11、e 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 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 Healt
12、h 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apro
13、tinin 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 = antibiotic-resistant gram-negative bacilli 耐药革兰阴性杆菌ARM11 组arrhyt
14、hmia 心律不齐arsenicals = arsenic compounds 砷化合物 artificial discs 人造脊椎5artificial 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 = AHW
15、P 医疗器械法规亚洲协调会aspartate aminotransferase = AST12 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assurance13 临床试验许可AST = antimicrobial susceptibility test 药敏试验
16、= 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 analysis14 接受治疗分析atopic dermatitis = AD 异位性皮炎atorvastatin 阿伐他汀系列 cholesterol-lowering drugATR = attenuated total refle
17、ction 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audit15 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
18、 cells 自体结构细胞Automated Broker Interface of the Automated 自动商业系统下的自动经纪人界面6Commercial System = ABI/ACSAutomated Commercial System 自动商业系统availability of water 有效水分Avandia (rosiglitazone)16 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 = Bacill
19、us 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 so
20、dium） 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benzodiazepine17 苯重氮基盐; 苯二氮卓类抗焦虑药 18benzoic 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
21、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bias19 偏倚bicohort study 双队列研究bilirubin 胆红素BIMO Bioresearch Monitoring Program 生物研究监测7bioavailability (F)20 生物利用度biochemical drugs 生化药品biocides 生物杀灭剂; 杀生物剂biocompatibility21 生物相容性;biodegradable 生物分解bio-engineered, transgenic foo
22、d 转基因食物bioequivalence; bioequivalent (i.e., performs in the same manner as the innovator drug生物等效biofilm22 细菌薄膜, 生物膜biologic23 生物制品biological response modifiers BRM24 生物应答调节剂biological therapeutic agents 生物治疗药剂biomarker25 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:
23、biopharmaceutical products 生物药物产品biosimilar26 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blind27 盲法blind codes 编制盲底blind review28 盲态审核blinding method 盲法blinding/ masking 盲法，设盲blister packaging 泡罩包装; 水泡
24、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8Board Certified rheumatologist 美国国内认证的风湿病学家Body Mass Index = BMI 体质指数bolus amo
25、unts 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
26、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calc
27、ium 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 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 Ef
28、fected” supplement (FDA)“正在进行修改” 补充申请CBP (U.S. Customs and Border Protection) 美国海关与边境保护局CCDS30 = company core data sheet 公司核心数据表CCFAC = Codex Committee on Food Additives and Contaminants食品添加剂和污染物法典委员会CCFH = Codex Committee on Food Hygiene 食品卫生法典委员会CCT = controlled clinical trial 对照临床试验CD = circular
29、dichroism 圆二色谱CDER = Center for Drug Evaluation 塞来考昔Center for Biologics, Food and Drug Administration生物制品中心Center For Food Safety and Applied Nutrition = CFSAN食品安全与应用营养中心CEP = Certificate of Suitability to the Monograph of the European Pharmacopoeia; Certificate of Suitability to the EP欧洲药典适应性证书cep
30、halosporins 头孢菌素类抗生素;cerebellar atrophy 小脑萎缩cerebellar malformation 小脑畸形;小脑发育畸形cerebral infarction 脑梗塞Cerezyme 伊米苷酶,治疗罕见戈谢病(高雪氏病 )10Certificate of Suitability to the EP (CEP) 欧洲药典适用性证书cetuximab; Erbitux33 爱必妥CFG = Certificate for Foreign Government 致外国政府证书CFR = code of federal regulations （美国）联邦法规;
31、美国联邦管理条例 CFSAN = Center For Food Safety and Applied Nutrition食品安全与应用营养中心CFU = colony forming unit 菌落形成单位cGMPs = current good manufacturing practice 现行生产质量管理规范CGMS = continuous glucose monitoring system 动态血糖监测Chagas disease (also called American trypanosomiasis)美洲锥虫病; 恰加斯病Challenge-dechallenge-rechal
32、lenge = CDR 给药-停药- 再次给药channeling bias 渠道偏倚CHB = customs house broker 报关行chemotherapeutics in seafood (aquaculture drug residues)药Chi-square test/Chi-Square Goodness-of-Fit Test 卡方检验Child-Pugh Child-Pugh 分级标准chlorambucil 苯丁酸氮芥CHMP = Committee for Medicinal Products for Human Use人用药品委员会cholestatic he
33、patitis 胆汁郁积型肝炎chromatography 色谱chronic obstructive pulmonary disease = COPD 慢性阻塞性肺疾病Chronic Wasting Disease (CWD) 鹿慢性消耗性疾病CIOMS = Council for International Organizations of Medical Sciences国际医学科学组织委员会circular dichroism34 = CD 圆二色谱; cirrhosis 肝硬化citation 传唤CJD = Creutzfeld-Jakob disease 克-雅病CL = cle
34、arance rate 清除率claims 宣示Cleaning Validation 清洗验证clearance rate = CL 清除率cleft palate 腭裂CLIA Clinical Laboratory Improvement Amendments临床实验室改进修订案11clinical (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 investigator35 临床研究者Clinical Pharmacists 临床药师Clini
35、cal 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 trial36 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clinic
36、ally significant results 有临床意义closed loop system 闭路系统Clostridium botulinum 肉毒杆菌Clostridium sporogenes 产孢梭菌;Cmax 峰浓度CMC = chemistry, manufacturing and control 化学、生产和控制CMS = Centers for Medicare 联合用药治疗commercial release 商业发行community-acquired bacterial pneumonia 社区获得性细菌性肺炎community-based clinical tria
37、l = CBCT38 基于社区的临床试验co-morbid condition 并存疾病; 共患病COMP= Committee for Orphan Medicinal Products罕用药委员会comparison 对照compassionate use39 体恤使用competitive labeling 优越标签complementary and alternative therapy40 补充性和非传统治疗complete response 完全有效complete response letter 完全回应函 (FDA 不批准通知)compliance 合规；遵守；对遵守法规情况的
38、监管compliance, patient 病人依从性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concentration = C 浓度cone beam CT, CBCT 锥形束 CTconfidence interval = CI 可信区间; 置信区间confidence level 置信水平confidentiality regarding trial participan
39、ts41 为试验参与者保密congenital analgesia 先天无痛congenital anomaly 先天性异常congenital long QT syndrome 先天性长 QT 综合征consignee 收货人consistency test 一致性检验context of vulnerability42 肿瘤的薄弱基因环境contract research organization = CRO 合同研究组织contraindication43 禁忌；禁忌症13contrast agent 造影剂control 对照control group44 对照组controlled
40、clinical trials 临床对照实验controlled trials45 对照试验convulsion 惊厥;又叫抽风coordinating committee 协调委员会coordinating investigator = COI 协调研究者CO-Oximeter, pulse 脉搏血氧计COPD = chronic obstructive pulmonary disease 慢性阻塞性肺疾病COPE = International Coalition of Pacing and Electrophysiology Organizations 国际整律与电生理学组织联盟coro
41、nary artery disease 冠状动脉疾病coronary heart disease = CHD 冠心病coronary stents 血管支架coronary vascular disease 冠状血管疾病cortical stimulation 刺激皮层cost overrun 成本超支;费用超支Covington and Burling, LLP limited liability partnership科温顿柏灵律师事务所COX = cyclooxygenase 细胞环氧化酶COX-2 inhibitor COX-2 抑制剂; e.g. 罗非昔布coxachie virus
42、 柯萨奇病毒Cp = Process Capability46 工序能力CPAP = Continuous Positive Airway Pressure 持续气道正压通气治疗(仪); for sleep apnea;CPDER = Center For Post-market Drug Evaluation and Research上市后药品评价研究中心Cpk = Process Capability Index47 工序能力指数CPMP = Committee for Proprietary Medicinal Product专卖医疗产品委员会CPP = Critical Process
43、 Parameter 关键工序参数CQA = critical quality attribute 关键质量属性cranial nerve 颅神经CRC = colorectal cancer 结直肠癌creatine48 = Cr 肌酸creatine kinase = CK 肌酸激酶creatinine49 = Cr/Crea 肌酐 gan14CRF = case report form 病例报告表Crimean-Congo haemorrhagic fever virus 克里米亚 刚果出血热病毒critical path 关键路径CRM = continual reassessment
44、 method 连续重新评估方法crossover design 交叉设计cross-over study50 交叉研究crossover therapy 交义治疗cryptosporidium parvum 小球隐孢子虫Css = steady-state concentration 稳态血药浓度; 稳浓度CT Computed tomography 计算机断层技术CTCAE = Common Terminology Criteria for Adverse Events 不良事件的通用术语标准CTD = Common Technical Document51 通用技术文件CTP = Com
45、prehensive Toxicological Profile 全面毒理学综述cure 痊愈CVMP = Committee for Medicinal Products for Veterinary Use兽用药品委员会CVTE = cardiovascular thrombolic events 心血管血栓栓塞事件CyA = cyclosporin A 环孢素 A; CYA mentality (Cover Your Ass) 明哲保身的心态cyanosis52 紫绀Cyclospora cayetanesis 圆孢子球虫cyclosporin A = CyA 环孢素 A; CYP53
46、= Cytochrome P450 (abbreviated P450, infrequently CYP450) 细胞色素 P450 酶CYP 2D6 poor metabolizer CYP 2D6 弱代谢者CYP probe substrates CYP 酶探针底物cystic fibrosis = CF 囊肿性纤维化，亦称为囊性纤维化、囊肿性纤维变性或囊纤维变性; 囊性纤维性变病cytokine 细胞因子cytokine storm 细胞因子风暴 54cytostatic 细胞抑制cytotoxic drugs 细胞毒性药物data mining 数据挖掘Data Safety And
47、 Monitoring Board = DSMB55 数据安全及监控委员会DBS = deep brain stimulation 脑深部电刺激技术DDMAC = Division of Drug Marketing, 药品销售、广告和信息处15Advertising, and Communicationsde novo acute myelogenic leukemia 初治急性髓性白血病de novo process56dear doctor letters 致医疗卫生人员的一封信dear healthcare professional letter 致医疗保健人员信件deep brain
48、 stimulators 深部脑刺激器degenerative disc disease 椎间盘退变； 椎骨退化疾病delayed effect 迟发反应deli meats 熟肉制品demographic risk factor 人口统计学风险因子Dengue virus 登革病毒denominator 分母dental reconstruction 埋植型牙齿改建； 牙再生denture cushions 假牙衬垫Department of Health and Human Services 卫生与公众服务部depression 抑郁(症)depyrogenation 去热原dermal
49、fibroblast 真皮成纤维细胞DES = Drug Eluting Stent; a.k.a “drug coated stents“ or “medicated stents“药物洗脱支架descriptive statistical analysis 描述性统计分析design space57 设计空间；design validation customer requirements 设计验证：确认符合客户需求design verification internal testing 设计确认：内部检验destructive analysis 破坏性分析detention 海关扣留detergent 除垢剂development value chain 开发价值链developmental toxicity 发育毒性deviation 偏差deviation/ Out of Specification (OOS) procedures 偏差/OOS（不合格）程序device listing 医疗器械产品登记DF = degree of fluctuation58 波动度DFS = disease free survival 无病生存期DHR = device history record
