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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 sequence氨基酸序列aminoglycoside antibiotics氨基糖苷类抗生素amphetamines安菲他明amyotrophic lateral sclerosis
