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1FDAGlossaryCompiledby:Yaw-TsongLeeLastupdated:November21,2010[Top][Laws&Regulations][FDAOrganization][SFDA国食药监]食品和药物管理局局长玛格丽特•汉堡(MargaretHamburg)2-(4-hydroxyphenyl)acetamide2-（4-羟苯基）乙酰胺AAA=abdominalaorticaneurysm腹主动脉瘤ABCs=airways，breathing，circulation气道、呼吸、循环ABI/ACS=AutomatedBrokerInterfaceoftheAutomatedCommercialSystem自动商业系统下的自动经纪人界面(CBP的自动商业系统)absorbablecollagensponge吸收性胶原海绵absorptionrateconstant/absorptionratecoefficientKa吸收速率常数/吸收速率系数abstinencesymptoms戒断症状acceleratedapproval加速批准accesstomedicine(ATM)有药品可使用ACCF=AmericanCollegeofCardiologyFoundation美国心脏病学会基金会accreditedschool立案学校accuracy准确度Accutane,abrandofisotretinoin异维生素A酸;异维A酸;异维甲酸;保肤灵ACEinhibitors=angiotensinconvertingenzymeinhibitors=ACEI血管紧张素转化酶抑制剂acetaminophen扑热息痛;对乙酰(xian)氨基酚acidreflux胃酸逆流acidifiedfood酸化食品ACR-20improvementcriteria(AmericanCollegeofRheumatology)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=AutomatedCommercialSystem自动商业系统ACTH=adrenocorticotropichormone促肾上腺皮质激素Actimmune(Interferongamma-1b)2干扰素微克—1bactionletter决定通知activecomparator活性对照药物；活性药物对照组activecontrol=AC阳性对照，活性对照activeingredient有效成分ActiveSubstanceMasterFile(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)acutemyocardialinfarction急性心肌梗死acutetibialfractures急性胫骨骨折adalimumab(Humira)阿达木单抗adaptivedesign自适应设计adaptiverandomization自适应随机ADE=adversedrugevent药物不良事件adenoviralvectors腺病毒载体adequateandwell-controlledstudies充分严格的对照研究ADHD=Attention-deficithyperactivitydisorder注意力缺陷多动障碍;注意力不足过动症;多动症2adhesionbarrierproduct防黏著产品adjuvant助剂;佐剂auxiliary;adjuvanttherapy佐药疗法，辅助疗法ADL=activitiesofdailyliving日常生活活动能力ADME=absorption,distribution,metabolism,andexcretion药物的吸收、分布、代谢和排泄ADR=adversedrugreaction药物不良反应adrenalcortex肾上腺皮质adrenalcorticalhormone肾上腺皮质激素adrenalgland肾上腺adrenaline肾上腺素adulterateddevices掺假器械adversedrugreaction=ADR药物不良反应adverseeffect副作用adverseevent=AE不良事件adversemedicalevents不良医学事件adversereaction(adverseevent)3药物不良反应advisory提醒advocacyandsupportgroups4倡导和支持团体AE=adverseevent5不良事件AERS=AdverseEventReportingSystem不良事件报告系统aflatoxin黄曲霉素;黄曲霉毒素africansleepingsickness非洲昏睡病;非洲锥虫病AFSSAPS=AgenceFrançaisedeSécuritéSanitairedesProduitsdeSanté法国卫生安全和健康产品委员会;法国医疗产品安全局aftereffect后遗效应agency审理部门（指FDA）AHA=AmericanHeartAssociation美国心脏病协会AIP=ApplicationIntegrityPolicy6alsoFraudPolicy防伪政策airembolism气体栓塞airhandling空气处理airlock阻隔室alanineaminotransferase=ALT7丙氨酸氨基转移酶ALARPregion(aslowasreasonablypracticable)尽合理可行程度的低Alb=albumin白蛋白AlcoholandTobaccoTaxandTradeBureauTTB烟酒税务和贸易局ALD=ApproximateLethalDose近似致死剂量ALF=acuteliverfailure急性肝功能衰竭alkalinephosphatase8=ALP碱性磷酸酶allergenicity致敏性allergicshock过敏性休克allograft9transplantation同种异体移植ALOP=AppropriateLevelofProtection适当的保护水平ALP=Alkalinephosphatase碱性磷酸酶alphaspendingfunction消耗函数ALS=amyotrophiclateralsclerosis;LouGehrig’sDisease肌萎缩性脊髓侧索硬化;渐冻症3ALT=alanineaminotransferase丙氨酸氨基转换酶Alzheimer’sDisease老年痴呆症;阿尔茨海默氏病aminoacidsequence氨基酸序列aminoglycosideantibiotics氨基糖苷类抗生素amphetamines安菲他明amyotrophiclateralsclerosis=ALS肌萎缩侧索硬化analysisofcovariance(ANCOVA)10协变量分析analysissets统计分析的数据集analyte待测物anaphylaxis过敏性反应ANDA=abbreviatednewdrugapplication简化新药申请anginapectoris心绞痛angioplastyballoons血管修复气囊animaltrial动物试验anotia无耳;又称“无耳畸形”antibioticprophylaxis预防性抗生素使用antibioticresistance抗生素抗性anti-inflammatoryagents抗炎药anti-metabolites干扰代谢药物antimicrobialresistance耐药性anti-nutrients抗营养素antipyretic，analgesicsandanti-inflammatorydrugs解热镇痛抗炎药anti-TNFagent;TNFblockerdrugs抗肿瘤坏死因子抑制剂anti-TNFtherapy抗TNF-α治疗AORN=AssociationofPerioperativeRegisteredNurses美国围手术注册护士协会aorticdisease主动脉疾病aorticstenosis主动脉瓣狭窄APEC亚太经济合作组织APHIS=AnimalandPlantHealthInspectionService动植物卫生检验局APIC=AssociationofProfessionalsofInfectionControlandEpidemiology美国感染控制和流行病专业协会APIs=activepharmaceuticalingredients原料药aplasticanemia再生障碍性贫血AppropriateLevelofProtection(ALOP)适当的保护水平approval批准approveddrugs已批准药物approximatelethaldose=ALD近似致死剂量aprotinin抑肽酶AQSIQ=China'sGeneralAdministrationforQualitySupervision,InspectionandQuarantine国家质量监督检验检疫总局;质检总局archivalcopy存档用副本AreaUndertheCurve=AUC;areaundertheplasmaconcentration-timecurve药时曲线下面积/血药浓度-时间曲线下面积ARGNB=antibiotic-resistantgram-negativebacilli耐药革兰阴性杆菌ARM11组arrhythmia心律不齐4arsenicals=arseniccompounds砷化合物artificialdiscs人造脊椎artificialheartvalve人工心脏瓣膜artificialpancreas人工胰脏AS=ankylosingspondylitis强直性脊柱炎ASCO=AmericanSocietyofClinicalOncology美国临床肿瘤学会ASD=atrialseptaldefect房间隔缺损asepticpackaging无菌包装AsianHarmonizationWorkingParty=AHWP医疗器械法规亚洲协调会aspartateaminotransferase=AST12天门冬氨酸氨基转移酶aspergillin曲霉菌素aspergillusflavus黄曲霉aspergillusochraceus赫曲霉ASR=alternativesummaryreportsassayconstancyCA检验恒定性assaysensitiviyAS检验灵敏度assistantinvestigator=AI助理研究者assurance13临床试验许可AST=antimicrobialsusceptibilitytest药敏试验=抗菌药物敏感性试验AST=aspartateaminotransferase天门冬酸氨基转换酶ASTMInternational(ASTM),originallyknownastheAmericanSocietyforTestingandMaterials美国材料与试验协会AstraZeneca阿斯利康as-treatedanalysis14接受治疗分析atopicdermatitis=AD异位性皮炎atorvastatin阿伐他汀系列cholesterol-loweringdrugATR=attenuatedtotalreflection衰减全反射法attenuatedtotalreflection=ATR衰减全反射法AUCss=areaundertheplasmaconcentration-timecurveatsteady-state稳态血药浓度－时间曲线下面积audit15稽查auditorins