FDA词汇说课材料

1、Good is good, but better carries it.精益求精，善益求善。FDA词汇FDAGlossaryCompiledby:Yaw-TsongLeeLastupdated:December14,2013HYPERLINKltopTopHYPERLINKllawLaws&RegulationsHYPERLINKlFDAorgFDAOrganizationHYPERLINKlSFDAorgSFDA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=abdominala

2、orticaneurysm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)ABMS=AmericanBoardofMedicalSpecialities美国医学专业委员会absorbablecollagensponge吸收性胶原海绵absorptionrateconstant/absorptionratecoefficientKa吸收速率常数/吸收速率系数abstinenc

3、esymptoms戒断症状AcceleratedApprovalregulationallowingearlierapprovalofdrugstotreatseriousdiseases,andthatfillanunmetmedicalneedbasedonasurrogateendpoint.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备案，立案学校accuracy准确度Accutane,abrandofisotretinoin异维(生

4、素)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;醋氨酚;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ACSoftheBureauofCustomsandBor

5、derProtection(CBP)=AutomatedCommercialSystem自动商业系统ACTH=adrenocorticotropichormone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；阳性药activeingredient有效成分Activ

6、eSubstanceMasterFile(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AD

7、HD=Attention-deficithyperactivitydisorder注意力缺陷多动障碍;注意力不足过动症;多动症adhesionbarrierproduct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administrativedetention行政扣留权ADR=adversedrugreaction药物不良反应adren

8、alcortex肾上腺皮质adrenalcorticalhormone肾上腺皮质激素adrenalgland肾上腺adrenaline肾上腺素adrenoceptor肾上腺受体adrenocorticalsteroids肾上腺皮质类固醇meadulterant掺杂物adulterateddevices掺假器械AdvaMed=AdvancedMedicalTechnologyAssociation,medicaltechnology(medicaldevices)tradeassociation先进医疗技术协会adventitiousinfectiousagents外来感染物adversedru

9、greaction=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advocacyandsupportgroupsOrganizationsandgroupsthatactivelysupportparticipantsandtheirfamilies

10、withvaluableresources,includingself-empowermentandsurvivaltools.倡导和支持团体AE=adverseeventAnegativeexperienceencounteredbyanindividualduringthecourseofaclinicaltrialthatisassociatedwiththedrug.不良事件AERS=AdverseEventReportingSystem;nowFDAAdverseEventReportingSystem(FAERS)不良事件报告系统;aflatoxin黄曲霉素;黄曲霉毒素africa

11、nsleepingsickness非洲昏睡病;非洲锥虫病AFSSAPS=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）agonist兴奋剂，激动剂，刺激物；竞争剂；拮抗剂AHA=AmericanHeartAssociation美国心脏病协会AIP=ApplicationIntegrityPolicyThebasicpremiseofAIPis:IfFDAdeterminesthatacompanysapplicationsarenotr

12、eliable,theagencywillnotperformsubstantivereviewofanyofthecompanysapplicationsuntilconfidenceinthedataisrestored.alsoFraudPolicy防伪政策airembolism气体栓塞airhandling空气处理airlock阻隔室alanineaminotransferase=ALTAnalanineaminotransferase(ALT)testmeasurestheamountofthisenzymeintheblood.ALTismeasuredtoseeifthelive

13、risdamagedordiseased.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alkalinephosphatasetocheckforliverdiseaseordamagetotheliver.Symptomsofliverdiseasecanincludejaundice,be

14、llypain,nausea,andvomiting.AnALPtestmayalsobeusedtochecktheliverwhenmedicinesthatcandamagetheliveraretakenortocheckboneproblems(sometimesfoundonX-rays),suchasrickets,osteomalacia,bonetumors,Pagetsdisease,ortoomuchofthehormonethatcontrolsbonegrowth(parathyroidhormone).=ALP碱性磷酸酶allergenicity致敏性allergi

15、cshock过敏性休克allogeneichematopoieticstemcell异基因造血干细胞allograftAnallograftisatransplantedorganortissuefromageneticallynon-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;LouGe

16、hrigsDisease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aminoacidsequence氨基酸序列aminoglycosideantibiotics氨基糖苷类抗生素amphetamines安菲他明;苯丙胺amyotrophiclateralsclerosis=ALS肌萎缩侧索硬化ANAAtestforantinuclearantibodies(ANA)testiscommoninpeoplewhoaresuspectedofhavinganautoimmuneorco

17、nnectivetissuedisorder.TheANAtestidentifiesautoantibodiesthattargetsubstancescontainedinthenucleusofcells=antinuclearantibodies抗核抗体analysisofcovariance(ANCOVA)isagenerallinearmodelwithacontinuousoutcomevariable(quantitative)andtwoormorepredictorvariableswhereatleastoneiscontinuous(quantitative)andat

18、leastoneiscategorical(qualitative).ANCOVAisamergerofANOVAandregressionforcontinuousvariables.ANCOVAtestswhethercertainfactorshaveaneffectontheoutcomevariableafterremovingthevarianceforwhichquantitativepredictors(covariates)account.Theinclusionofcovariatescanincreasestatisticalpowerbecauseitaccountsf

19、orsomeofthevariability协变量分析analysissets统计分析的数据集analyte待测物anaphylaxis过敏性反应;过敏休克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antihistamine抗组胺剂Anti-Infective抗感染药物anti-inflammatorya

20、gents抗炎药anti-metabolites抗代谢物;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-治疗AORN=AssociationofPerioperativeRegisteredNurses美国围手术注册护士协会aorticdisease主动脉疾病aorticdissection主动脉夹层aorticste

21、nosis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/DrugSubstance(bulkdrugsubstances)原料药/活性药用成分aplasticanemia=pancytopenia再生障碍性贫血AppropriateLevelofProtection(ALOP)

22、适当的保护水平approval批准approveddrugs已批准药物approximatelethaldose=ALD近似致死剂量AnnualProductReviews(APR)年度产品审查aprotinin抑肽酶AQSIQ=ChinasGeneralAdministrationforQualitySupervision,InspectionandQuarantine国家质量监督检验检疫总局;质检总局arachidonicacid花生四烯酸Arava=leflunomide爱若华（来氟米特）archivalcopy存档用副本AreaUndertheCurve=AUC;areaunderth

23、eplasmaconcentration-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arteryinfusion动脉滴注artificialdiscs人造脊椎artificialheartvalve人工心脏瓣膜artificialpancreas人工胰脏AS=ankylosingspondyl

24、itis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.Whenbodytissueoranorgansuchastheheartorliverisdiseasedordamaged,additionalASTisre

25、leasedintothebloodstream.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assistantinvestigator=AI助理研究者assuranceArenewablepermitgrantedbyth

26、efederalgovernmenttoaninstitutionorresearchcentertoconductclinicaltrials.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-treatedanalysisinanastreat

27、ed(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=ATR衰减全反射法AUCss=areaundertheplasmaconcentration-timecur

28、veatsteady-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autologousstructuralcells自体结构细胞AutomatedBrokerInterfaceoftheAutomatedComm

29、ercialSystem=ABI/ACS自动商业系统下的自动经纪人界面AutomatedCommercialSystem自动商业系统autonomicneuropathy自主神经病变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Avastin=Bevacizumab阿瓦斯丁;抗血管内皮生长因子单克隆嵌合抗体AventisPharma安万特医药averageconcentration/averageconcentrationvalue=Cav平均浓度B.Cereus=Bacilluscer

30、eus蜡状芽孢杆菌B.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BayerSchering

31、Pharma拜耳先灵医药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，chlordiazepo

32、xide，商品名Librium)、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

33、局BHC=BayerHealthCare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bioc

34、hemicaldrugs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;bioequivalenti.e.,performsinthesamemannerastheinnovatordrug生物等效biofilm

35、Abiofilmisastructuredcommunityofmicroorganismsencapsulatedwithinaself-developedpolymericmatrixandadherenttoalivingorinertsurface细菌薄膜,生物膜biologicAvirus,therapeuticserum,toxin,antitoxin,vaccine,blood,bloodcomponentorderivative,allergenicproduct,oranalogousproductapplicabletotheprevention,treatmentorcu

36、reofdiseasesorinjuriesofman.biologicaltherapeuticagentsthatincludebloodandbloodproducts,vaccines,allergenics,cellandtissue-basedproducts,andgenetherapyproducts生物制品biologicalresponsemodifiersBRMSubstancesthatstimulatethebodysresponsetoinfectionanddisease.Thebodynaturallyproducessmallamountsofthesesub

37、stances.ScientistscanproducesomeoftheminthelaboratoryinlargeamountsforuseintreatingHYPERLINK/script/main/art.asp?articlekey=13931cancer,HYPERLINK/script/main/art.asp?articlekey=466rheumatoidarthritis,andotherdiseases生物应答调节剂biologicaltherapeuticagents生物治疗药剂biomarkerAbiochemicalfeatureorfacetthatcanbe

38、usedtomeasuretheprogressofdiseaseortheeffectsoftreatment生物标志物biometrics生物统计;生物识别技术bionstimulator生物体刺激器bionicknee仿生膝关节biopharma:biopharmaceuticalproducts生物药物产品biosimilarBiosimilarsorFollow-onbiologicsaretermsusedtodescribeofficially-approvedsubsequentversionsofinnovatorbiopharmaceuticalproductsmadeby

39、adifferentsponsorfollowingpatentandexclusivityexpiryontheinnovatorproduct.Biosimilarsarealsoreferredtoassubsequententrybiologics(SEBs)inCanada生物仿制药，生物类似物，生物拟似物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混合过程是固体制剂生产的重要环节，对于保证制剂活性成

40、分分布均匀、质量长期稳定具有重要意义。混合不充分将导致药品质量严重不均一，而混合过久则是不必要的浪费能源混合均匀度分析blindArandomizedtrialisBlindiftheparticipantisnottoldwhicharmofthetrialheison.AclinicaltrialisBlindifparticipantsareunawareonwhethertheyareintheexperimentalorcontrolarmofthestudy;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

41、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bloodbiochemistry血生化bloodthinner血液稀释药bloodureanitrogen=BUN尿素氮BlueBookMemorandaOneoftheresponsibilitiesoftheOfficeofDeviceEvaluation(ODE)istodevelopandint

42、erpretregulationsandguidelinesregardingpremarketnotificationsubmissions(510(k)s),premarketapprovalapplications(PMAs),productdevelopmentprotocols(PDPs),deviceclassifications,andinvestigationaldeviceexemptions(IDEs).TheODEguidancememoranda,affectionatelyreferredtoasBlueBookMemos,clarifytheseguidelines

43、,ODEBMP=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BoardCertified专科认证BoardCertifiedrheumatologist美国专科认证的风湿病学家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brachytherapy

44、seeds放射性粒子源近距离治疗bradycardia心动过缓BreakthroughTherapyDesignationThisnewdesignationhelpsFDAassistdrugdeveloperstoexpeditethedevelopmentandreviewofnewdrugswithpreliminaryclinicalevidencethatindicatesthedrugmayofferasubstantialimprovementoveravailabletherapiesforpatientswithseriousorlife-threateningdiseas

45、es突破性疗法认定breastimplants,Polyurethane-coated乳房植入物,聚亚安酯包囊;隆胸bromfenac溴xi酚酸BSE=BovineSpongiformEncephalopathy;madcowdisease疯牛病;牛海绵状脑病BsUFA(BiosimilarUserFeeAct)生物相似药品用户费用法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(proteoly

46、tic)=Clostridiumbotulinum肉毒梭状芽孢杆菌（蛋白质水解型）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=correctiveactionplanbydrugs

47、ponsor纠正行动计划CAPA(Corrective&PreventiveAction)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Cardia

48、cEP(electrophysiology)心脏电力生理cardiacresynchronizationtherapy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cartilagematrix软骨基质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CB

49、C=completebloodcount血常规CBEsupplement“ChangesBeingEffected”supplement(FDA)“正在进行修改”补充申请CBP(U.S.CustomsandBorderProtection)美国海关与边境保护局CCDSBoththeFDAandEMEAendorsetheuseofCCDSstotracksafetydataandsharelabelinginformation.TheEMEArequirescompaniestofilePeriodicSafetyUpdateReports(PSURs)regularlyandtheFDAre

50、quirespostmarketingreportsforsomedrugscurrentlyonthemarketandlikelymoreinthefuture=companycoredatasheet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CCyRoccursinthetreatmentofCMLwhencytogenetictestingi

51、sunabletodetectthePhiladelphia(Ph)chromosomeinbonemarroworbloodcells(0%Ph+cells)=completecytogeneticresponse细胞遗传学完全应答CD=circulardichroism圆二色谱CDER=CenterforDrugEvaluation&Research药品审评和研究中心CDRamedicaltestingprotocolinwhichamedicineordrugisadministered,withdrawn,thenre-administered,whilebeingmonitoredf

52、oradverseeffectsateachstage.Theprotocolisusedwhenstatisticaltestingisinappropriateduetoanidiosyncraticreactionbyaspecificindividual,oralackofsufficienttestsubjectsandunitofanalysisistheindividualChallenge-dechallenge-rechallenge给药-停药-再次给药CDRH=CenterforDevicesandRadiologicalHealth器械与辐射保健中心CEmark(anac

53、ronymfortheFrenchConformiteEuropeenne)certifiesthataproducthasmetEUhealth,safety,andenvironmentalrequirements,whichensureconsumersafetyCE认证标记Celebrex(celecoxib)西乐葆；COX2特异性抑制剂;塞来考昔cellbank细胞库cellline细胞株censoring【统计】-删截CenterforBiologics,FoodandDrugAdministration生物制品中心CenterForFoodSafetyandAppliedNutr

54、ition=CFSAN食品安全与应用营养中心CEP=CertificateofSuitabilitytotheMonographoftheEuropeanPharmacopoeia;CertificateofSuitabilitytotheEP欧洲药典适应性证书cephalosporins头孢菌素类抗生素;cerebellaratrophy小脑萎缩cerebellarmalformation小脑畸形;小脑发育畸形cerebralinfarction脑梗塞Cerezyme伊米苷酶,治疗罕见戈谢病(高雪氏病)CertificateofSuitabilitytotheEP(CEP)欧洲药典适用性证书

55、cetuximab;Erbituxapprovedforcoloncancer,aswellasheadandneckcancer爱必妥CFG=CertificateforForeignGovernment致外国政府证书CFR=codeoffederalregulations（美国）联邦法规;美国联邦管理条例CFSAN=CenterForFoodSafetyandAppliedNutrition食品安全与应用营养中心CFU=colonyformingunit菌落形成单位cGMPs=currentgoodmanufacturingpractice现行生产质量管理规范CGMS=continuous

56、glucosemonitoringsystem动态血糖监测Chagasdisease(alsocalledAmericantrypanosomiasis)美洲锥虫病;恰加斯病Challenge-dechallenge-rechallenge=CDR给药-停药-再次给药ChangeControlAformalsystembywhichqualifiedrepresentativesofappropriatedisciplinesreviewproposedoractualchangesthatmightaffectthevalidatedstatusoffacilities,systems,eq

57、uipmentorprocesseschannelingbiasChannelingisaformofallocationbias,wheredrugswithsimilartherapeuticindicationsareprescribedtogroupsofpatientswithprognosticdifferences.Claimedadvantagesofanewdrugmaychannelittopatientswithspecialpre-existingmorbidity,withtheconsequencethatdiseasestatescanbeincorrectlya

58、ttributedtouseofthedrug.Forthestudyofadversedrugreactions,largedatabasessupplyinformationonco-medicationandmorbidityofpatients.Fordiseaseswithastepped-careapproach,thedrughistoryofpatients,asavailablefromsomedatabases,canshowchannelingofdrugstopatientswithmarkersofrelativelyseveredisease.渠道偏倚CHB=cus

59、tomshousebroker报关行chemotherapeuticsinseafood(aquaculturedrugresidues)药Child-PughChild-Pugh分级标准Chi-squaretest/Chi-SquareGoodness-of-FitTest卡方检验chlorambucil苯丁酸氮芥CHMP=CommitteeforMedicinalProductsforHumanUse人用药品委员会cholestatichepatitis胆汁郁积型肝炎Cholestyramine考来烯胺CHR=Completehematologicresponseoccursinthetr

60、eatmentofCMLwhenbloodcellcountsreturntonormal,therearenoimmaturecellsvisibleintheblood,andthespleenreturnstonormalsize血液学完全应答chromatography色谱chronicmyelocyticleukemia,chronicgranulocyticleukemia,CML,CGL慢性粒细胞白血病chronicobstructivepulmonarydisease=COPD慢性阻塞性肺疾病ChronicWastingDisease(CWD)鹿慢性消耗性疾病CIOMS=Cou