FDA术语词汇讲解学习.doc

《FDA术语词汇讲解学习.doc》由会员分享，可在线阅读，更多相关《FDA术语词汇讲解学习.doc（224页珍藏版）》请在淘文阁 - 分享文档赚钱的网站上搜索。

1、Good is good, but better carries it.精益求精，善益求善。FDA术语词汇-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absorptionra

2、teconstant/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=angiotensinconvertingenzymeinhi

3、bitors=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ACSoftheBureauofCustomsandBorderProtection(CBP)=AutomatedCommercialSystem自动商业系统ACTH=adrenoc

4、orticotropichormone促肾上腺皮质激素Actimmune(Interferongamma-1b)abiologicresponsemodifier,isasingle-chainpolypeptidecontaining140aminoacids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

5、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adh

6、esionbarrierproduct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a

7、dversedrugreaction=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)Anunwantedeffectcausedbytheadministrationofdrugs.Onsetmaybesuddenordevelopovertime药物不良反应advisory提醒advocacyandsupportgroupsOrganizationsandgroupsthatactivelysupportparticipantsandthei

8、rfamilieswithvaluableresources,includingself-empowermentandsurvivaltools.倡导和支持团体AE=adverseeventAnegativeexperienceencounteredbyanindividualduringthecourseofaclinicaltrialthatisassociatedwiththedrug.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AFSSA

9、PS=AgenceFranaisedeScuritSanitairedesProduitsdeSant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=ApplicationIntegrityPolicyThebasicpremiseofAIPis:IfFDAdeterminesthatacompanysapplicationsarenotreliable,theagencywillnotperformsubstantivereviewofanyofthec

10、ompanysapplicationsuntilconfidenceinthedataisrestored.alsoFraudPolicy防伪政策airembolism气体栓塞airhandling空气处理airlock阻隔室alanineaminotransferase=ALTAnalanineaminotransferase(ALT)testmeasurestheamountofthisenzymeintheblood.ALTismeasuredtoseeiftheliverisdamagedordiseased.丙氨酸氨基转移酶ALARPregion(aslowasreasonablyp

11、racticable)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alkalinephosphatasetocheckforliverdiseaseordamagetotheliver.Symptomsofliverdiseasecanincludejaundice,bellypain,nausea,andvomiting.AnALPtestmayalsobeusedtocheckthe

12、liverwhenmedicinesthatcandamagetheliveraretakenortocheckboneproblems(sometimesfoundonX-rays),suchasrickets,osteomalacia,bonetumors,Pagetsdisease,ortoomuchofthehormonethatcontrolsbonegrowth(parathyroidhormone).=ALP碱性磷酸酶allergenicity致敏性allergicshock过敏性休克allograftAnallograftisatransplantedorganortissue

13、fromageneticallynon-identicalmemberofthesamespeciestransplantation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;LouGehrigsDisease肌萎缩性脊髓侧索硬化;渐冻症ALT=alanineaminotransferase丙氨酸氨基转换酶AlzheimersDisease老年痴呆症;阿尔茨海默氏病aminoac

14、idsequence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)isagenerallinearmodelwithacontinuousoutcomevariable(quantitative)andtwoormorepredictorvariableswhereatleastoneiscontinuous(quantitative)andatleastoneiscategorical(qualita

15、tive).ANCOVAisamergerofANOVAandregressionforcontinuousvariables.ANCOVAtestswhethercertainfactorshaveaneffectontheoutcomevariableafterremovingthevarianceforwhichquantitativepredictors(covariates)account.Theinclusionofcovariatescanincreasestatisticalpowerbecauseitaccountsforsomeofthevariability协变量分析an

16、alysissets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

17、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-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=AssociationofProf

18、essionalsofInfectionControlandEpidemiology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=ChinasGeneralAdministrationforQualitySupervision,InspectionandQuar

19、antine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ARMAnyofthetreatmentgroupsinarandomizedtrial.组arrhythmia心律不齐arsenicals=arseniccompounds砷化合物artificialdiscs人造脊椎artificialhea

20、rtvalve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=ASTLowlevelsofASTarenormallyfoundintheblood.Whenbodytissueoranorgansuc

21、hastheheartorliverisdiseasedordamaged,additionalASTisreleasedintothebloodstream.TheamountofASTinthebloodisdirectlyrelatedtotheextentofthetissuedamage.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assistanti

22、nvestigator=AI助理研究者assuranceArenewablepermitgrantedbythefederalgovernmenttoaninstitutionorresearchcentertoconductclinicaltrials.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),originallyknownastheAmericanSocietyforTestingandMateria

23、ls美国材料与试验协会AstraZeneca阿斯利康as-treatedanalysisinanastreated(orobserveddata)analysisonlythosepatientsstilltakingtheassignedtreatmentareanalyzed;thosewhodropoutarecensored.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

24、=ATR衰减全反射法AUCss=areaundertheplasmaconcentration-timecurveatsteady-state稳态血药浓度时间曲线下面积audit指由不直接涉及试验的人员所进行的一种系统性检查，以评价试验的实施、数据的记录和分析是否与试验方案、标准操作规程以及药物临床试验相关法规要求相符稽查auditorinspection稽查视察auditreport稽查报告auditor稽查员autoimmunedisease,AID自身免疫病autologousmarrowstemcelltransplantation自体骨髓干细胞移植autologousstructur

25、alcells自体结构细胞AutomatedBrokerInterfaceoftheAutomatedCommercialSystem=ABI/ACS自动商业系统下的自动经纪人界面AutomatedCommercialSystem自动商业系统availabilityofwater有效水分Avandia(rosiglitazone)一种批准用于治疗2型糖尿病的药物商品名：文迪雅；通用名：罗格列酮AventisPharma安万特医药averageconcentration/averageconcentrationvalue=Cav平均浓度B.Cereus=Bacilluscereus蜡状芽孢杆菌B

26、.atrophaeus草芽孢杆菌黑色变种bacilli芽孢杆菌Bacillusanthracis炭疽芽胞杆菌bacterialendospores细菌芽孢bacterialspore细菌孢子barcode条(形)码barbiturates巴比妥盐basalmetabolicrate基础代谢率baseline基线basiliximab(tradenameSimulect)舒莱;治疗肾移植排斥药batchproduction批量生产；分批生产batchrelease批放行Baycol（cerivastatinsodium）拜斯亭;西立伐他汀;降血脂新药BayerScheringPharma拜耳先灵

27、医药BCGBostonConsultingGroup波士顿咨询公司benchtest实验室试验benefit受益benzodiazepineBenzodiazepineshavealsobeenusedasadaterapedrugbecausetheycanmarkedlyimpairandevenabolishfunctionsthatnormallyallowapersontoresistorevenwanttoresistsexualaggressionorassault苯重氮基盐;苯二氮卓类抗焦虑药本类药物也称弱安定药，包括氯氮卓(利眠宁，chlordiazepoxide，商品名Li

28、brium)、地西泮(安定，diazepam，商品名valium)、硝西泮(硝基安定，nitrazepam)、氟西泮(氟安定，flurazepam)及奥沙西泮(去甲羟基安定，舒宁，oxazepam)。临床主要用于镇静、催眠及对抗癫痫benzoicacid安息香酸BestPharmaceuticalsforChildrenAct2002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=BundesinstitutfrArzneimittelundMedizinprodukte德国联邦药品和医疗器械管理局BHC=Bayer

29、HealthCare拜耳医药保健有限公司bias指在设计临床试验方案、执行临床试验、分析评价临床试验结果时，有关影响因素所致的系统误差，致使疗效或安全性评价偏离真值。偏倚bicohortstudy双队列研究bilirubin胆红素BIMOBioresearchMonitoringProgram生物研究监测bioavailability(F)expressionofhowmuchdrugreachesthecirculation(knowntopharmacologistsasthecentralcompartment)afteradministration生物利用度biochemicaldru

30、gs生化药品biocides生物杀灭剂;杀生物剂biocompatibilityThepropertyofbeingbiologicallycompatiblebynotproducingatoxic,injurious,orimmunologicalresponseinlivingtissue生物相容性;biodegradable生物分解bio-engineered,transgenicfood转基因食物bioequivalence;bioequivalent(i.e.,performsinthesamemannerastheinnovatordrug生物等效biofilmAbiofilmi

31、sastructuredcommunityofmicroorganismsencapsulatedwithinaself-developedpolymericmatrixandadherenttoalivingorinertsurface细菌薄膜,生物膜biologicAvirus,therapeuticserum,toxin,antitoxin,vaccine,blood,bloodcomponentorderivative,allergenicproduct,oranalogousproductapplicabletotheprevention,treatmentorcureofdisea

32、sesorinjuriesofman.biologicaltherapeuticagentsthatincludebloodandbloodproducts,vaccines,allergenics,cellandtissue-basedproducts,andgenetherapyproducts生物制品biologicalresponsemodifiersBRMSubstancesthatstimulatethebodysresponsetoinfectionanddisease.Thebodynaturallyproducessmallamountsofthesesubstances.S

33、cientistscanproducesomeoftheminthelaboratoryinlargeamountsforuseintreatingcancer,rheumatoidarthritis,andotherdiseases生物应答调节剂biologicaltherapeuticagents生物治疗药剂biomarkerAbiochemicalfeatureorfacetthatcanbeusedtomeasuretheprogressofdiseaseortheeffectsoftreatment生物标志物biometrics生物统计;生物识别技术bionstimulator生物体

34、刺激器bionicknee仿生膝关节biopharma:biopharmaceuticalproducts生物药物产品biosimilarBiosimilarsorFollow-onbiologicsaretermsusedtodescribeofficially-approvedsubsequentversionsofinnovatorbiopharmaceuticalproductsmadebyadifferentsponsorfollowingpatentandexclusivityexpiryontheinnovatorproduct.Biosimilarsarealsoreferre

35、dtoassubsequententrybiologics(SEBs)inCanada生物类似物bipolar双极燥郁症birthdefect出生缺陷,新生儿缺陷,先天缺陷BLA=biologiclicenseapplication生物制品许可申请blankcontrol空白对照blenduniformityanalysis混合均匀度分析blindArandomizedtrialisBlindiftheparticipantisnottoldwhicharmofthetrialheison.AclinicaltrialisBlindifparticipantsareunawareonwheth

36、ertheyareintheexperimentalorcontrolarmofthestudy;alsocalledmasked盲法blindcodes编制盲底blindreview在最后一份病例报告表输入数据库后，第一次揭盲之前对数据保持盲态的预分析审核，以便对统计分析计划作最后的决定。盲态审核blindingmethod盲法blinding/masking盲法，设盲blisterpackaging泡罩包装;水泡眼block分段;层blocksize每段的长度blockedrandomization区组随机bloodthinner血液稀释药bloodureanitrogen=BUN尿素氮B

37、MP=bonemorphogeneticproteins骨形成蛋白BMS（Bristol-MyersSquibb）百时美施贵宝公司BNF=biotechnologynotificationfile生物工程通报档案BoardCertifiedrheumatologist美国国内认证的风湿病学家BodyMassIndex=BMI体质指数bolusamounts大剂量bonegrafting骨移植bonemarrowsuppression骨髓抑制botulinum肉毒杆菌botulism肉毒中毒boxedwarnings黑框警告brachytherapyseeds放射性粒子源近距离治疗bradyca

38、rdia心动过缓breastimplants,Polyurethane-coated乳房植入物,聚亚安酯包囊;隆胸bromfenac溴酚酸BSE=BovineSpongiformEncephalopathy;madcowdisease疯牛病;牛海绵状脑病BU=BusinessUnits事业单位bubbleleaktest漏泄气泡测试BUN=bloodureanitrogen尿素氮BureauofCustomsandBorderProtection=CBP美国海关与边境保护局C.botulinum(proteolytic)=Clostridiumbotulinum肉毒梭状芽孢杆菌（蛋白质水解型）

39、CABG=coronaryarterybypassgraft冠状动脉旁路移植术;冠状动脉搭桥手术CAGR=CompoundAnnualGrowthRate年均复合增长率calciumantagonists钙拮抗剂calciumchannelblockers=CCB钙道阻滞剂calibration校准;标定campylobacter弯曲杆菌campylobacterfetus胚胎弯曲杆菌campylobacterJejuni空肠弯杆菌cannulas套管CAP=correctiveactionplanbydrugsponsor纠正行动计划CAPA(Corrective&PreventiveAct

40、ion)system纠正与预防措施系统CapitationAflatmonthlyfeethatahealthplanpaystoaprovider(doctor,hospital,lab,etc.)totakecareofapatientsneeds.Capitationispartoftheprovider-reimbursementmechanism按人头付费carcinogenicriskassessment,proceduresfor致癌风险评估程序cardiacarrhythmia心律失常CardiacEP(electrophysiology)心脏电力生理cardiacresync

41、hronizationtherapy心脏再同步化治疗CarelinkMonitorCarelink监护carryovereffect延滞效应Carticel组织工程软骨移植疗法casehistory病历caserecordform=CRF病例报告表/病例记录表casereportform病例报告表cashcurve现金曲线cashtrap现金陷阱;现金套牢categoricalvariable分类变量catheters导管cathlabbypass导管室搭桥Cav平均浓度CBEsupplement“ChangesBeingEffected”supplement(FDA)“正在进行修改”补充申请

42、CBP(U.S.CustomsandBorderProtection)美国海关与边境保护局CCDSBoththeFDAandEMEAendorsetheuseofCCDSstotracksafetydataandsharelabelinginformation.TheEMEArequirescompaniestofilePeriodicSafetyUpdateReports(PSURs)regularlyandtheFDArequirespostmarketingreportsforsomedrugscurrentlyonthemarketandlikelymoreinthefuture=co

43、mpanycoredatasheet公司核心数据表CCFAC=CodexCommitteeonFoodAdditivesandContaminants食品添加剂和污染物法典委员会CCFH=CodexCommitteeonFoodHygiene食品卫生法典委员会CCT=controlledclinicaltrial对照临床试验CD=circulardichroism圆二色谱CDER=CenterforDrugEvaluation&Research药品审评和研究中心CDRamedicaltestingprotocolinwhichamedicineordrugisadministered,with

44、drawn,thenre-administered,whilebeingmonitoredforadverseeffectsateachstage.Theprotocolisusedwhenstatisticaltestingisinappropriateduetoanidiosyncraticreactionbyaspecificindividual,oralackofsufficienttestsubjectsandunitofanalysisistheindividualChallenge-dechallenge-rechallenge给药-停药-再次给药CDRH=CenterforDe

45、vicesandRadiologicalHealth器械与辐射保健中心CEmark(anacronymfortheFrenchConformiteEuropeenne)certifiesthataproducthasmetEUhealth,safety,andenvironmentalrequirements,whichensureconsumersafetyCE认证标记Celebrex(celecoxib)西乐葆；COX2特异性抑制剂;塞来考昔CenterforBiologics,FoodandDrugAdministration生物制品中心CenterForFoodSafetyandAppliedNutrition=CFSAN食品安全与应用营养中心CEP=CertificateofSuitabilitytotheMonographoftheEuropeanPharmacopoeia;CertificateofSuitabilitytotheEP欧洲药典适应性证书