细胞色素P450酶FDAGlossarylistUnitedNationsInterpreters.docx

1、细胞色素P450酶FDAGlossarylistUnitedNationsInterpretersFDA Glossary Compiled by: Yawtsong LeeLast updated: September 16, 2016Top Laws & Regulations FDA Organization SFDA国食药监食品和药物管理局局长Robert M. Califf, MD2-(4-hydroxyphenyl) acetamide 2 -（ 4 -羟qing苯基）乙酰胺AAA = abdominal aortic aneurysm腹主动脉瘤ABCs = airways，bre

2、athing，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)ABMS = American Board of Medical Specialities美国医学专业委员会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 symptom

3、s戒断症状ACA = Patient Protection and Affordable Care Act; Obamacare 患者保护与平价医疗法案; 奥巴马医改Accelerated Approval regulation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 备案，立案学校accuracy准确度Accutane, a brand of isotretinoin异维(生素) A酸;异维甲酸; 保肤灵ACE

4、 inhibitors = angiotensin converting enzyme inhibitors = ACEI血管紧张素转化酶抑制剂acetaminophen扑热息痛; 醋氨酚;对乙酰(xian)氨基酚acid reflux胃酸逆流acidified food酸化食品ACO: Accountable Care Organization责任制医疗组织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

5、%acrylamide 丙烯酰胺ACS = 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)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；阳性药active ingredient有效成分Active Substance Master File (ASMF) 欧洲药物主文件Actos (pioglitazon

6、e)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Adalat XL (Nifedipine Extended Release Tablets) by Bayer硝苯地平缓释片; 拜新同, 心痛定、艾克地平adalimumab (Humira)阿达木单抗adaptive design自适应设计adaptive randomization自适应随机ADC Antibody Drug Conjugates抗体-药物偶联剂ADE = adverse drug e

7、vent药物不良事件adenosine腺苷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, di

8、stribution, metabolism, and excretion药物的吸收、分布、代谢和排泄administrative detention行政扣留权ADP Adenosine diphosphate 腺嘌呤核甘二磷酸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adrenoceptor 肾上腺受体adrenocortical steroids肾上腺皮质类固醇meadulterant掺杂物 adult

9、erated devices掺假器械 AdvaMed = Advanced Medical Technology Association, medical technology (medical devices) trade association 先进医疗技术协会adventitious infectious agents外来感染物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

10、) 药物不良反应advisory提醒Advisory Committee on Medical Uses of Isotopes ACMUI（美国）同位素医用咨询委员会advocacy and support groups倡导和支持团体AE = adverse event 不良事件AERS = Adverse Event Reporting System; now FDA Adverse Event Reporting System (FAERS) 不良事件报告系统; aflatoxin 黄曲霉素; 黄曲霉毒素Aflibercept阿柏西普african sleeping sickness非洲

11、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）agonist 兴奋剂，激动剂，刺激物；竞争剂；拮抗剂agonist, partial部分激动药AHA = American Heart Association 美国心脏病协会 AI = aromatase inhibitor芳香酶抑制药AIP = Application Integrity Policy also Fraud Po

12、licy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 phospha

13、tase = ALP 碱性磷酸酶alkylating agent烷化剂allele等位基因allergenicity致敏性allergic shock过敏性休克allogeneic hematopoietic stem cell异基因造血干细胞allograft transplantation同种异体移植allosteric AKT inhibitor变构Akt 抑制剂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 = amy

14、otrophic 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Ambien (Zolpidem)唑吡坦，赛诺菲研制安眠药amino acid sequence氨基酸序列aminoglycoside antibiotics氨基糖苷类抗生素amphetamines安菲他明; 苯丙胺amyotrophic lateral sclerosis = ALS肌萎缩侧索硬化ANA = antinuclear a

15、ntibodies 抗核抗体analysis of covariance (ANCOVA)协变量分析analysis sets 统计分析的数据集analyte待测物; 分析物Analyte specific reagents ASRs分析物特异性试剂anaphylaxis过敏性反应; 过敏休克ANDA = abbreviated new drug application 简化新药申请angina pectoris心绞痛angioplasty血管成形术angioplasty balloons血管修复气囊animal trial 动物试验Annual Product Reviews (APR)年度

16、产品审查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antihistamine 抗组胺剂Anti-Infective抗感染药物 anti-inflammatory agents抗炎药anti-metabolites抗代谢物; 干扰代谢药物antimicrobial resistance 耐药性anti-neoplastic agent抗肿瘤药anti-nutrients抗营养素antipyretic，analgesics and anti-inflammatory drugs解热镇痛抗炎药a

17、nti-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 dissection主动脉夹层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

18、 Infection Control and Epidemiology美国感染控制和流行病专业协会APIs = active pharmaceutical ingredients / Drug Substance (bulk drug substances)原料药 / 活性药用成分aplastic anemia = pancytopenia再生障碍性贫血apoptotic细胞凋亡的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

19、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arachidonic acid 花生四烯酸Arava = leflunomide爱若华（来氟米特）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 = antibiot

20、ic-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 artery infusion动脉滴注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

21、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 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化验assay constancy CA检验恒定性assay sensitiviy AS检验灵敏度assistant investigator = AI助理研究者

22、assurance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阿托伐他汀非诺贝特

23、片cholesterol-lowering drugATP adenosine triphosphate 腺嘌呤核甘三磷酸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稽查audit or inspection 稽查视察audit report稽查报告auditor稽查员autoimmune disease, A

24、ID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autonomic neuropathy自主神经病变autophosphorylation自体磷酸化availability of water有效水分Avandia (rosig

25、litazone)商品名：文迪雅；通用名：罗格列酮Avastin = Bevacizumab阿瓦斯丁; 贝伐单抗; 抗血管内皮生长因子单克隆嵌合抗体Avelox (Moxifloxacin) by Bayer莫西沙星; 拜复乐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 endospor

26、es 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BCPNN (Bayesian

27、Confidence Neural Network)贝叶斯置信传播神经网络法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Betaferon/ Betaseron (Interferon Beta-1B) by Bayer倍泰龙（干扰素-1b）Bextra (valdecoxib)伐地考昔(镇痛类药物)BfARM = Bundesinstitut fr Arzn

28、eimittel 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(监督)项目binding antibody结合抗体bioassay 生物检定bioavailability (F)生物利用度bioburden菌落总数biochemical drugs生化药品biocides生物杀灭剂; 杀生物剂biocompatibility生物相容性;biodeg

29、radable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Biologics Price Competition and Innovation Act (BPCI Act）生物药价格竞争及创新法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生物药物产品biopharmaceutic studybiosimilar生物仿制药，生物类似物，生物拟似物bipolar双极燥郁症birth d