FDA醫(yī)藥英文詞匯

1、FDA 醫(yī)藥英文詞匯Compiled by: Yaw-Tsong LeeLast updated: November 21, 2010 Top Laws & Regulations FDA Organization SFDA 國食藥監(jiān) 食品和藥物管理局局長瑪格麗特 ?漢堡 (Margaret Hamburg)2-(4-hydroxyphenyl) acetamideAAA = abdominal aortic aneurysmABCs = airways ， breathing ， circulationABI/ACS = Automated Broker Interface of theAu

2、tomated Commercial Systemabsorbable collagen spongeabsorption rate constant/absorption rate coefficient Kaabstinence symptomsaccelerated approvalaccess to medicine (ATM)ACCF = American College of Cardiology Foundationaccredited schoolaccuracyAccutane, a brand of isotretinoinACE inhibitors = angioten

3、sin converting enzyme inhibitors = ACEIacetaminophenacid refluxacidified foodACR-20 improvement criteria (American College of Rheumatology)acrylamideACS 1 = Automated Commercial System ACTH = adrenocorticotropic hormone Actimmune (Interferon gamma-1 b) 2 action letteractive comparatoractive control

4、= ACactive ingredientActive Substance Master File (ASMF)Actos (pioglitazone)acute myocardial infarctionacute tibial fracturesadalimumab (Humira)adaptive designadaptive randomizationADE = adverse drug eventadenoviral vectorsadequate and well-controlled studies2 - （ 4 -羥苯基）乙酰胺腹主動脈瘤氣道、呼吸、循環(huán)自動商業(yè)系統(tǒng)下的自動經(jīng)紀

5、人界面(CBP 的自動商業(yè)系統(tǒng) )吸收性膠原海綿吸收速率常數(shù)/吸收速率系數(shù)戒斷癥狀加速批準有藥品可使用美國心臟病學會基金會立案學校準確度異維生素 A 酸 ; 異維 A 酸 ;異維甲酸 ; 保膚靈血管緊張素轉(zhuǎn)化酶抑制劑撲熱息痛 ; 對乙酰 (xian) 氨基酚胃酸逆流酸化食品美國風濕病學會類風濕關節(jié)炎改善的基本定義要求觸痛關節(jié)數(shù)減少 20% 腫脹關節(jié)數(shù)減少 20% 加上以下五條中三條好轉(zhuǎn) 20%丙烯酰胺自動商業(yè)系統(tǒng)促腎上腺皮質(zhì)激素干擾素微克 1b決定通知活性對照藥物；活性藥物對照組陽性對照，活性對照有效成分歐洲藥物主文件艾可拓 (匹格列酮 ) (日本武田制藥公司 Takeda 的糖尿病藥物 )急

6、性心肌梗死急性脛骨骨折阿達木單抗自適應設計自適應隨機藥物不良事件腺病毒載體充分嚴格的對照研究ADHD = Attention-deficit hyperactivity disorder adhesion barrier productadjuvantadjuvant therapyADL = activities of daily livingADME = absorption, distribution, metabolism, and excretionADR = adverse drug reactionadrenal cortexadrenal cortical hormoneadr

7、enal glandadrenalineadulterated devicesadverse drug reaction = ADRadverse effectadverse event = AEadverse medical events3adverse reaction (adverse event)4advocacy and support groups5AE = adverse eventAERS = Adverse Event Reporting System aflatoxinafrican sleeping sicknessAFSSAPS = Agence Fran? aise

8、de S curitSanitairedes Produits de Santafter effectagencyAHA = American Heart AssociationAIP = Application Integrity Policy 6 also Fraud Policyair embolismair handlingair lockalanine aminotransferase = ALT 7ALARP region (as low as reasonably practicable)Alb = albuminAlcohol and Tobacco Tax and Trade

9、 Bureau TTB ALD = Approximate Lethal DoseALF = acute liver failure8alkaline phosphatase= ALPallergic shockallograft 9 transplantationALOP = Appropriate Level of Protection ALP = Alkaline phosphatase alpha spending functionALS = amyotrophic lateral sclerosis; Lou Gehrigs注意力缺陷多動障礙 ; 注意力不足過動癥 ; 多動癥防黏著產(chǎn)

10、品助劑 ; 佐劑 auxiliary;佐藥療法，輔助療法日常生活活動能力藥物的吸收、分布、代謝和排泄藥物不良反應腎上腺皮質(zhì)腎上腺皮質(zhì)激素腎上腺腎上腺素摻假器械藥物不良反應副作用不良事件不良醫(yī)學事件藥物不良反應提醒倡導和支持團體不良事件不良事件報告系統(tǒng)黃曲霉素 ; 黃曲霉毒素非洲昏睡病; 非洲錐蟲病法國衛(wèi)生安全和健康產(chǎn)品委員會 ; 法國醫(yī)療產(chǎn)品安全局后遺效應審理部門（指FDA ）美國心臟病協(xié)會防偽政策氣體栓塞空氣處理阻隔室丙氨酸氨基轉(zhuǎn)移酶盡合理可行程度的低白蛋白煙酒稅務和貿(mào)易局近似致死劑量急性肝功能衰竭堿性磷酸酶致敏性過敏性休克同種異體移植適當?shù)谋Ｗo水平堿性磷酸酶消耗函數(shù)肌萎縮性脊髓側(cè)索硬化;

11、漸凍癥DiseaseALT = alanine aminotransferaseAlzheimer s Diseaseamino acid sequenceaminoglycoside antibioticsamphetaminesamyotrophic lateral sclerosis = ALS10analysis of covariance (ANCOVA)analysis setsanalyteanaphylaxisANDA = abbreviated new drug application angina pectorisangioplasty balloonsanimal tri

12、alanotiaantibiotic prophylaxisantibiotic resistanceanti-inflammatory agentsanti-metabolitesantimicrobial resistanceanti-nutrientsantipyretic ， analgesics and anti-inflammatory drugsanti-TNF agent; TNF blocker drugs anti-TNF therapyAORN = Association of Perioperative Registered Nursesaortic diseaseao

13、rtic stenosisAPECAPHIS = Animal and Plant Health Inspection ServiceAPIC = Association of Professionals of Infection Control and EpidemiologyAPIs = active pharmaceutical ingredients aplastic anemiaAppropriate Level of Protection (ALOP)approvalapproved drugsapproximate lethal dose = ALDaprotininAQSIQ

14、= Chinas General Administration for Quality Supervision, Inspection and Quarantine archival copyArea Under the Curve = AUC; area under the plasma concentration-time curveARGNB = antibiotic-resistant gram-negative bacilli ARM 11丙氨酸氨基轉(zhuǎn)換酶老年癡呆癥;阿爾茨海默氏病氨基酸序列氨基糖苷類抗生素安菲他明肌萎縮側(cè)索硬化協(xié)變量分析統(tǒng)計分析的數(shù)據(jù)集待測物過敏性反應簡化新藥申請心

15、絞痛血管修復氣囊動物試驗無耳 ;又稱 “無耳畸形 ”預防性抗生素使用抗生素抗性抗炎藥干擾代謝藥物耐藥性抗營養(yǎng)素解熱鎮(zhèn)痛抗炎藥抗腫瘤壞死因子抑制劑抗 TNF- 治療美國圍手術注冊護士協(xié)會主動脈疾病主動脈瓣狹窄亞太經(jīng)濟合作組織動植物衛(wèi)生檢驗局美國感染控制和流行病專業(yè)協(xié)會原料藥再生障礙性貧血適當?shù)谋Ｗo水平批準已批準藥物近似致死劑量抑肽酶國家質(zhì)量監(jiān)督檢驗檢疫總局; 質(zhì)檢總局存檔用副本藥時曲線下面積/血藥濃度 -時間曲線下面積耐藥革蘭陰性桿菌組arrhythmia心律不齊arsenicals = arsenic compounds砷化合物artificial discs人造脊椎artificial he

16、art valve人工心臟瓣膜artificial pancreas人工胰臟AS = ankylosing spondylitis強直性脊柱炎ASCO = American Society of Clinical Oncology美國臨床腫瘤學會ASD = atrial septal defect房間隔缺損aseptic packaging無菌包裝Asian Harmonization Working Party = AHWP醫(yī)療器械法規(guī)亞洲協(xié)調(diào)會aspartate aminotransferase = AST 12天門冬氨酸氨基轉(zhuǎn)移酶aspergillin曲霉菌素aspergillus fl

17、avus黃曲霉aspergillus ochraceus赫曲霉ASR = alternative summary reportsassay constancy CA檢驗恒定性assay sensitiviy AS檢驗靈敏度assistant investigator = AI助理研究者assurance13臨床試驗許可AST = antimicrobial susceptibility test藥敏試驗 = 抗菌藥物敏感性試驗AST = aspartate aminotransferase天門冬酸氨基轉(zhuǎn)換酶ASTM International (ASTM), originally known

18、as美國材料與試驗協(xié)會the American Society for Testing and MaterialsAstraZeneca阿斯利康as-treated analysis14接受治療分析atopic dermatitis = AD異位性皮炎atorvastatin阿伐他汀系列 cholesterol-lowering drugATR = attenuated total reflection衰減全反射法attenuated total reflection = ATR衰減全反射法AUCss = area under the plasma concentration-time穩(wěn)態(tài)血藥

19、濃度時間曲線下面積curve at steady-stateaudit 15稽查audit or inspection稽查視察audit report稽查報告auditor稽查員autoimmune disease, AID自身免疫病autologous marrow stem cell transplantation自體骨髓干細胞移植autologous structural cells自體結(jié)構(gòu)細胞Automated Broker Interface of the Automated自動商業(yè)系統(tǒng)下的自動經(jīng)紀人界面Commercial System = ABI/ACSAutomated Com

20、mercial System自動商業(yè)系統(tǒng)availability of water有效水分Avandia (rosiglitazone) 16商品名：文迪雅；通用名：羅格列酮Aventis Pharma安萬特醫(yī)藥average concentration/average concentration value平均濃度= CavB. Cereus = Bacillus cereus蠟狀芽孢桿菌B.atrophaeus草芽孢桿菌黑色變種bacilli芽孢桿菌Bacillus anthracisbacterial endosporesbacterial sporebar codebarbiturat

21、esbasal metabolic ratebaselinebasiliximab (trade name Simulect)batch productionbatch releaseBaycol （ cerivastatin sodium ）Bayer Schering PharmaBCG Boston Consulting Groupbench testbenefit17benzodiazepineBest Pharmaceuticals for Children Act 2002 beta-blockerBextra (valdecoxib)BHC = Bayer HealthCare1

22、9biasbicohort studybilirubinBIMO Bioresearch Monitoring Program bioavailability (F) 20biochemical drugsbiocides21biocompatibilitybio-engineered, transgenic foodbioequivalence; bioequivalent (i.e., performs in the same manner as the innovator drug22biofilm23biologicbiological response modifiers BRM24

23、biological therapeutic agentsbiomarker 25biometricsbion stimulatorbionic kneebiopharma: biopharmaceutical products biosimilar 26bipolarbirth defectBLA = biologic license application炭疽芽胞桿菌細菌芽孢細菌孢子條 (形)碼巴比妥鹽基礎代謝率基線舒萊 ; 治療腎移植排斥藥批量生產(chǎn)；分批生產(chǎn)批放行拜斯亭 ;西立伐他汀; 降血脂新藥拜耳先靈醫(yī)藥波士頓咨詢公司實驗室試驗受益18苯重氮基鹽; 苯二氮卓類抗焦慮藥安息香酸最好的兒

24、童醫(yī)藥品法案-受體阻滯劑伐地考昔 (鎮(zhèn)痛類藥物)德國聯(lián)邦藥品和醫(yī)療器械管理局拜耳醫(yī)藥保健有限公司偏倚雙隊列研究膽紅素生物研究監(jiān)測生物利用度生化藥品生物殺滅劑; 殺生物劑生物相容性;生物分解轉(zhuǎn)基因食物生物等效細菌薄膜 , 生物膜生物制品生物應答調(diào)節(jié)劑生物治療藥劑生物標志物生物統(tǒng)計 ; 生物識別技術生物體刺激器仿生膝關節(jié)生物藥物產(chǎn)品生物類似物雙極燥郁癥出生缺陷 , 新生兒缺陷, 先天缺陷生物制品許可申請blank controlblend uniformity analysis27blind codes28blinding methodblinding/ maskingblister packag

25、ingblockblock sizeblocked randomizationblood thinnerblood urea nitrogen = BUNBMP = bone morphogenetic proteinsBMS （ Bristol-Myers Squibb ） BNF = biotechnology notification file Board Certified rheumatologist Body Mass Index = BMIbolus amountsbone graftingbone marrow suppressionbotulinumbotulismboxed

26、 warningsbrachytherapy seedsbradycardiabreast implants, Polyurethane-coated bromfenacBSE = Bovine Spongiform Encephalopathy; mad cow diseaseBU = Business Unitsbubble leak testBUN = blood urea nitrogenBureau of Customs and Border Protection = CBP C. botulinum (proteolytic) = Clostridium botulinum CAB

27、G = coronary artery bypass graftCAGR = Compound Annual Growth Rate calcium antagonistscalcium channel blockers = CCBcalibrationcampylobactercampylobacter fetuscampylobacter JejunicannulasCAP = corrective action plan by drug sponsor CAPA (Corrective & Preventive Action) system Capitation 29carcinogen

28、ic risk assessment, procedures for空白對照混合均勻度分析盲法編制盲底盲態(tài)審核盲法盲法，設盲泡罩包裝 ; 水泡眼分段 ;層每段的長度區(qū)組隨機血液稀釋藥尿素氮骨形成蛋白百時美施貴寶公司生物工程通報檔案美國國內(nèi)認證的風濕病學家體質(zhì)指數(shù)大劑量骨移植骨髓抑制肉毒桿菌肉毒中毒黑框警告放射性粒子源近距離治療心動過緩乳房植入物, 聚亞安酯包囊;隆胸溴酚酸瘋牛病 ;牛海綿狀腦病事業(yè)單位漏泄氣泡測試尿素氮美國海關與邊境保護局肉毒梭狀芽孢桿菌（蛋白質(zhì)水解型）冠狀動脈旁路移植術 ; 冠狀動脈搭橋手術年均復合增長率鈣拮抗劑鈣道阻滯劑校準;標定彎曲桿菌胚胎彎曲桿菌空腸彎桿菌套管糾正行動計

29、劃糾正與預防措施系統(tǒng)按人頭付費致癌風險評估程序cardiac arrhythmiaCardiac EP (electrophysiology) cardiac resynchronization therapy Carelink Monitorcarryover effectCarticelcase historycase record form = CRFcase report formcash curvecash trapcategorical variablecatheterscathlab bypassCavCBE supplement “ Changes Being Effected

30、 supplement (FDA)CBP (U.S. Customs and Border Protection)30CCFAC = Codex Committee on Food Additives and ContaminantsCCFH = Codex Committee on Food Hygiene CCT = controlled clinical trialCD = circular dichroismCDER = Center for Drug Evaluation & Research CDR 31 Challenge-dechallenge-rechallengeCDRH

31、= Center for Devices and Radiological Health32CE markCenter for Biologics, Food and Drug Administration Center For Food Safety and Applied Nutrition =CFSANCEP = Certificate of Suitability to the Monograph of the European Pharmacopoeia; Certificate of Suitability to the EPcephalosporinscerebellar atr

32、ophycerebellar malformationcerebral infarctionCerezymeCertificate of Suitability to the EP (CEP)33CFG = Certificate for Foreign Government CFR = code of federal regulationsCFSAN = Center For Food Safety and Applied NutritionCFU = colony forming unitcGMPs = current good manufacturing practice心律失常心臟電力

33、生理心臟再同步化治療Carelink 監(jiān)護延滯效應組織工程軟骨移植療法病歷病例報告表/病例記錄表病例報告表現(xiàn)金曲線現(xiàn)金陷阱 ; 現(xiàn)金套牢分類變量導管導管室搭橋平均濃度” “正在進行修改”補充申請美國海關與邊境保護局公司核心數(shù)據(jù)表食品添加劑和污染物法典委員會食品衛(wèi)生法典委員會對照臨床試驗圓二色譜藥品審評和研究中心給藥 -停藥 - 再次給藥器械與輻射保健中心CE 認證標記西樂葆； COX 2 特異性抑制劑 ; 塞來考昔生物制品中心食品安全與應用營養(yǎng)中心歐洲藥典適應性證書頭孢菌素類抗生素;小腦萎縮小腦畸形 ;小腦發(fā)育畸形腦梗塞伊米苷酶 ,治療罕見戈謝病(高雪氏病 )歐洲藥典適用性證書愛必妥致外國政府

34、證書（美國）聯(lián)邦法規(guī) ; 美國聯(lián)邦管理條例食品安全與應用營養(yǎng)中心菌落形成單位現(xiàn)行生產(chǎn)質(zhì)量管理規(guī)范CGMS = continuous glucose monitoring systemChagas disease (also called Americantrypanosomiasis)Challenge-dechallenge-rechallenge = CDRchanneling biasCHB = customs house brokerchemotherapeutics in seafood (aquaculture drug residues)Chi-square test/Chi-S

35、quare Goodness-of-Fit Test Child-PughchlorambucilCHMP = Committee for Medicinal Products for Human Use動態(tài)血糖監(jiān)測美洲錐蟲病; 恰加斯病給藥 -停藥 - 再次給藥渠道偏倚報關行藥卡方檢驗Child-Pugh 分級標準苯丁酸氮芥人用藥品委員會cholestatic hepatitis膽汁郁積型肝炎chromatography色譜chronic obstructive pulmonary disease = COPD慢性阻塞性肺疾病Chronic Wasting Disease (CWD)鹿慢性消

36、耗性疾病CIOMS = Council for International Organizations國際醫(yī)學科學組織委員會of Medical Sciencescircular dichroism 34 = CD圓二色譜 ;cirrhosis肝硬化citation傳喚CJD = Creutzfeld-Jakob disease克 -雅病CL = clearance rate清除率claims宣示Cleaning Validation清洗驗證clearance rate = CL清除率cleft palate腭裂CLIA Clinical Laboratory Improvement臨床實驗室

37、改進修訂案Amendmentsclinical (human) data臨床數(shù)據(jù)clinical endpoint臨床終點clinical equivalence臨床等效應clinical hold臨床試驗暫停通知clinical investigator 35臨床研究者Clinical Pharmacists臨床藥師Clinical Research Coordinator = CRC臨床研究協(xié)調(diào)者clinical study臨床研究Clinical Study Application = CSA臨床研究申請clinical study report臨床試驗的總結(jié)報告clinical tri

38、al 36臨床試驗clinical trial application = CTA臨床試驗申請clinical trial exemption = CTX臨床試驗免責clinical trial protocol = CTP臨床試驗方案Clinical Trial Report = CTR臨床試驗報告clinically significant results有臨床意義closed loop system閉路系統(tǒng)Clostridium botulinum肉毒桿菌Clostridium sporogenesCmaxCMC = chemistry, manufacturing and contro

39、l CMS = Centers for Medicare & Medicaid ServicesCMS = Compliance Management System CMS = Concerned Member States CMV = Cytomegalovirus CNS abnormalitiesCOA = certificate of analysisco-administered drugcoatingCodex Alimentariuscoexistent physiological stateCOGS = Cost of goods sold37cohort studiesco-

40、investigator = CIcolonization (of bacteria)colony- stimulating factors (CSF, GM-CSF, G-CSF)colorectal cancer (CRC)combination productcombination therapycommercial releasecommunity-acquired bacterial pneumonia38community-based clinical trial = CBCT co-morbid conditionCOMP= Committee for Orphan Medici

41、nal Products comparison39compassionate usecomplementary and alternative therapy 40 complete responsecomplete response lettercompliancecompliance, patientcomposite variablecompression testcomputer-assisted trial design = CATD con meds = concomitant medications concentration = Ccone beam CT, CBCTconfi

42、dence interval = CIconfidence level41confidentiality regarding trial participants congenital analgesiacongenital anomaly產(chǎn)孢梭菌 ;峰濃度化學、生產(chǎn)和控制美國老年醫(yī)療保險基金中心與窮人醫(yī)療救助基金服務中心(拜耳醫(yī)藥保健有限公司的 )規(guī)范管理系統(tǒng)有關成員國巨細胞病毒中樞神經(jīng)系統(tǒng)異常分析證書合并用藥；與其它藥物聯(lián)合使用涂層國際食品法典委員會并存生理狀況主營業(yè)務成本隊列隊列研究合作研究者寄殖集落刺激因子結(jié)直腸癌復合產(chǎn)品組合用藥 ; 聯(lián)合用藥治療商業(yè)發(fā)行社區(qū)獲得性細菌性肺炎基于社區(qū)的

43、臨床試驗并存疾病 ; 共患病罕用藥委員會對照體恤使用優(yōu)越標簽補充性和非傳統(tǒng)治療完全有效完全回應函(FDA 不批準通知)合規(guī)；遵守；對遵守法規(guī)情況的監(jiān)管病人依從性復合變量壓縮試驗計算機輔助試驗設計聯(lián)合用藥濃度錐形束 CT可信區(qū)間 ; 置信區(qū)間置信水平為試驗參與者保密先天無痛先天性異常congenital long QT syndromeconsigneeconsistency testcontext of vulnerability42contract research organization = CROcontraindication 43contrast agentcontrolcontr

44、ol group 44controlled clinical trialscontrolled trials 45convulsioncoordinating committeecoordinating investigator= COICO-Oximeter, pulseCOPD = chronic obstructive pulmonary disease COPE = International Coalition of Pacing and Electrophysiology Organizationscoronary artery diseasecoronary heart dise

45、ase = CHDcoronary stentscoronary vascular diseasecortical stimulationcost overrunCovington and Burling, LLP limited liability partnershipCOX = cyclooxygenaseCOX-2 inhibitorcoxachie virusCp = Process Capability 46CPAP = Continuous Positive Airway Pressure CPDER = Center For Post-market Drug Evaluatio

46、n and ResearchCpk = Process Capability Index 47CPMP = Committee for Proprietary Medicinal ProductCPP = Critical Process ParameterCQA = critical quality attributecranial nerveCRC = colorectal cancer48creatine= Crcreatine kinase = CK49creatinine= Cr/CreaCrimean-Congo haemorrhagic fever virus critical

47、pathCRM = continual reassessment method crossover design先天性長QT 綜合征收貨人一致性檢驗腫瘤的薄弱基因環(huán)境合同研究組織禁忌；禁忌癥造影劑對照對照組臨床對照實驗對照試驗驚厥 ;又叫抽風協(xié)調(diào)委員會協(xié)調(diào)研究者脈搏血氧計慢性阻塞性肺疾病國際整律與電生理學組織聯(lián)盟冠狀動脈疾病冠心病血管支架冠狀血管疾病刺激皮層成本超支 ;費用超支科溫頓 ?柏靈律師事務所細胞環(huán)氧化酶COX-2 抑制劑 ; e.g. 羅非昔布柯薩奇病毒工序能力持續(xù)氣道正壓通氣治療 ( 儀); for sleep apnea; 上市后藥品評價研究中心工序能力指數(shù)專賣醫(yī)療產(chǎn)品委員會關鍵

48、工序參數(shù)關鍵質(zhì)量屬性顱神經(jīng)結(jié)直腸癌肌酸肌酸激酶肌酐 gan病例報告表克里米亞 剛果出血熱病毒關鍵路徑連續(xù)重新評估方法交叉設計cross-over study 50crossover therapycryptosporidium parvumCss = steady-state concentrationCT Computed tomographyCTCAE = Common Terminology Criteria for Adverse Events51CTD = Common Technical DocumentCTP = Comprehensive Toxicological Profile cureCVMP = Committee for Medicinal Products for Veterinary UseCVTE = cardiovascular thrombolic events CyA = cyclosporin ACYA mentality (Cover Your Ass)52Cyclospora cayetanesi