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1、Good is good, but better carries it.精益求精,善益求善。FDA醫(yī)藥英文詞匯FDAGlossaryCompiledby:Yaw-TsongLeeLastupdated:November21,2010HYPERLINKltopTopHYPERLINKllawLaws&RegulationsHYPERLINKlFDAorgFDAOrganizationHYPERLINKlSFDAorgSFDA國(guó)食藥監(jiān)食品和藥物管理局局長(zhǎng)瑪格麗特漢堡(MargaretHamburg)2-(4-hydroxyphenyl)acetamide2-(4-羥苯基)乙酰胺AAA=abdomi

2、nalaorticaneurysm腹主動(dòng)脈瘤ABCs=airways,breathing,circulation氣道、呼吸、循環(huán)ABI/ACS=AutomatedBrokerInterfaceoftheAutomatedCommercialSystem自動(dòng)商業(yè)系統(tǒng)下的自動(dòng)經(jīng)紀(jì)人界面(CBP的自動(dòng)商業(yè)系統(tǒng))absorbablecollagensponge吸收性膠原海綿absorptionrateconstant/absorptionratecoefficientKa吸收速率常數(shù)/吸收速率系數(shù)abstinencesymptoms戒斷癥狀acceleratedapproval加速批準(zhǔn)accessto

3、medicine(ATM)有藥品可使用ACCF=AmericanCollegeofCardiologyFoundation美國(guó)心臟病學(xué)會(huì)基金會(huì)accreditedschool立案學(xué)校accuracy準(zhǔn)確度Accutane,abrandofisotretinoin異維生素A酸;異維A酸;異維甲酸;保膚靈ACEinhibitors=angiotensinconvertingenzymeinhibitors=ACEI血管緊張素轉(zhuǎn)化酶抑制劑acetaminophen撲熱息痛;對(duì)乙酰(xian)氨基酚acidreflux胃酸逆流acidifiedfood酸化食品ACR-20improvementcrit

4、eria(AmericanCollegeofRheumatology)美國(guó)風(fēng)濕病學(xué)會(huì)類風(fēng)濕關(guān)節(jié)炎改善的基本定義要求觸痛關(guān)節(jié)數(shù)減少20%腫脹關(guān)節(jié)數(shù)減少20%加上以下五條中三條好轉(zhuǎn)20%acrylamide丙烯酰胺ACSoftheBureauofCustomsandBorderProtection(CBP)=AutomatedCommercialSystem自動(dòng)商業(yè)系統(tǒng)ACTH=adrenocorticotropichormone促腎上腺皮質(zhì)激素Actimmune(Interferongamma-1b)abiologicresponsemodifier,isasingle-chainpolypep

5、tidecontaining140aminoacids干擾素微克1bactionletter決定通知activecomparator活性對(duì)照藥物;活性藥物對(duì)照組activecontrol=AC陽(yáng)性對(duì)照,活性對(duì)照activeingredient有效成分ActiveSubstanceMasterFile(ASMF)歐洲藥物主文件Actos(pioglitazone)艾可拓(匹格列酮)(日本武田制藥公司Takeda的糖尿病藥物)acutemyocardialinfarction急性心肌梗死acutetibialfractures急性脛骨骨折adalimumab(Humira)阿達(dá)木單抗adaptiv

6、edesign自適應(yīng)設(shè)計(jì)adaptiverandomization自適應(yīng)隨機(jī)ADE=adversedrugevent藥物不良事件adenoviralvectors腺病毒載體adequateandwell-controlledstudies充分嚴(yán)格的對(duì)照研究ADHD=Attention-deficithyperactivitydisorder注意力缺陷多動(dòng)障礙;注意力不足過(guò)動(dòng)癥;多動(dòng)癥adhesionbarrierproduct防黏著產(chǎn)品adjuvant助劑;佐劑auxiliary;adjuvanttherapy佐藥療法,輔助療法ADL=activitiesofdailyliving日常生活活動(dòng)

7、能力ADME=absorption,distribution,metabolism,andexcretion藥物的吸收、分布、代謝和排泄ADR=adversedrugreaction藥物不良反應(yīng)adrenalcortex腎上腺皮質(zhì)adrenalcorticalhormone腎上腺皮質(zhì)激素adrenalgland腎上腺adrenaline腎上腺素adulterateddevices摻假器械adversedrugreaction=ADR藥物不良反應(yīng)adverseeffect副作用adverseevent=AE不良事件adversemedicalevents不良醫(yī)學(xué)事件adversereaction

8、(adverseevent)Anunwantedeffectcausedbytheadministrationofdrugs.Onsetmaybesuddenordevelopovertime藥物不良反應(yīng)advisory提醒a(bǔ)dvocacyandsupportgroupsOrganizationsandgroupsthatactivelysupportparticipantsandtheirfamilieswithvaluableresources,includingself-empowermentandsurvivaltools.倡導(dǎo)和支持團(tuán)體AE=adverseeventAnegative

9、experienceencounteredbyanindividualduringthecourseofaclinicaltrialthatisassociatedwiththedrug.不良事件AERS=AdverseEventReportingSystem不良事件報(bào)告系統(tǒng)aflatoxin黃曲霉素;黃曲霉毒素africansleepingsickness非洲昏睡病;非洲錐蟲病AFSSAPS=AgenceFranaisedeScuritSanitairedesProduitsdeSant法國(guó)衛(wèi)生安全和健康產(chǎn)品委員會(huì);法國(guó)醫(yī)療產(chǎn)品安全局aftereffect后遺效應(yīng)agency審理部門(指FD

10、A)AHA=AmericanHeartAssociation美國(guó)心臟病協(xié)會(huì)AIP=ApplicationIntegrityPolicyThebasicpremiseofAIPis:IfFDAdeterminesthatacompanysapplicationsarenotreliable,theagencywillnotperformsubstantivereviewofanyofthecompanysapplicationsuntilconfidenceinthedataisrestored.alsoFraudPolicy防偽政策airembolism氣體栓塞airhandling空氣處理a

11、irlock阻隔室alanineaminotransferase=ALTAnalanineaminotransferase(ALT)testmeasurestheamountofthisenzymeintheblood.ALTismeasuredtoseeiftheliverisdamagedordiseased.丙氨酸氨基轉(zhuǎn)移酶ALARPregion(aslowasreasonablypracticable)盡合理可行程度的低Alb=albumin白蛋白AlcoholandTobaccoTaxandTradeBureauTTB煙酒稅務(wù)和貿(mào)易局ALD=ApproximateLethalDose

12、近似致死劑量ALF=acuteliverfailure急性肝功能衰竭alkalinephosphatasetocheckforliverdiseaseordamagetotheliver.Symptomsofliverdiseasecanincludejaundice,bellypain,nausea,andvomiting.AnALPtestmayalsobeusedtochecktheliverwhenmedicinesthatcandamagetheliveraretakenortocheckboneproblems(sometimesfoundonX-rays),suchasricke

13、ts,osteomalacia,bonetumors,Pagetsdisease,ortoomuchofthehormonethatcontrolsbonegrowth(parathyroidhormone).=ALP堿性磷酸酶allergenicity致敏性allergicshock過(guò)敏性休克allograftAnallograftisatransplantedorganortissuefromageneticallynon-identicalmemberofthesamespeciestransplantation同種異體移植ALOP=AppropriateLevelofProtectio

14、n適當(dāng)?shù)谋Wo(hù)水平ALP=Alkalinephosphatase堿性磷酸酶alphaspendingfunction消耗函數(shù)ALS=amyotrophiclateralsclerosis;LouGehrigsDisease肌萎縮性脊髓側(cè)索硬化;漸凍癥ALT=alanineaminotransferase丙氨酸氨基轉(zhuǎn)換酶AlzheimersDisease老年癡呆癥;阿爾茨海默氏病aminoacidsequence氨基酸序列aminoglycosideantibiotics氨基糖苷類抗生素amphetamines安菲他明amyotrophiclateralsclerosis=ALS肌萎縮側(cè)索硬化an

15、alysisofcovariance(ANCOVA)isagenerallinearmodelwithacontinuousoutcomevariable(quantitative)andtwoormorepredictorvariableswhereatleastoneiscontinuous(quantitative)andatleastoneiscategorical(qualitative).ANCOVAisamergerofANOVAandregressionforcontinuousvariables.ANCOVAtestswhethercertainfactorshaveanef

16、fectontheoutcomevariableafterremovingthevarianceforwhichquantitativepredictors(covariates)account.Theinclusionofcovariatescanincreasestatisticalpowerbecauseitaccountsforsomeofthevariability協(xié)變量分析analysissets統(tǒng)計(jì)分析的數(shù)據(jù)集analyte待測(cè)物anaphylaxis過(guò)敏性反應(yīng)ANDA=abbreviatednewdrugapplication簡(jiǎn)化新藥申請(qǐng)anginapectoris心絞痛ang

17、ioplastyballoons血管修復(fù)氣囊animaltrial動(dòng)物試驗(yàn)anotia無(wú)耳;又稱“無(wú)耳畸形”antibioticprophylaxis預(yù)防性抗生素使用antibioticresistance抗生素抗性anti-inflammatoryagents抗炎藥anti-metabolites干擾代謝藥物antimicrobialresistance耐藥性anti-nutrients抗?fàn)I養(yǎng)素antipyretic,analgesicsandanti-inflammatorydrugs解熱鎮(zhèn)痛抗炎藥anti-TNFagent;TNFblockerdrugs抗腫瘤壞死因子抑制劑anti-TN

18、Ftherapy抗TNF-治療AORN=AssociationofPerioperativeRegisteredNurses美國(guó)圍手術(shù)注冊(cè)護(hù)士協(xié)會(huì)aorticdisease主動(dòng)脈疾病aorticstenosis主動(dòng)脈瓣狹窄APEC亞太經(jīng)濟(jì)合作組織APHIS=AnimalandPlantHealthInspectionService動(dòng)植物衛(wèi)生檢驗(yàn)局APIC=AssociationofProfessionalsofInfectionControlandEpidemiology美國(guó)感染控制和流行病專業(yè)協(xié)會(huì)APIs=activepharmaceuticalingredients原料藥aplastica

19、nemia再生障礙性貧血AppropriateLevelofProtection(ALOP)適當(dāng)?shù)谋Wo(hù)水平approval批準(zhǔn)approveddrugs已批準(zhǔn)藥物approximatelethaldose=ALD近似致死劑量aprotinin抑肽酶AQSIQ=ChinasGeneralAdministrationforQualitySupervision,InspectionandQuarantine國(guó)家質(zhì)量監(jiān)督檢驗(yàn)檢疫總局;質(zhì)檢總局archivalcopy存檔用副本AreaUndertheCurve=AUC;areaundertheplasmaconcentration-timecurve藥

20、時(shí)曲線下面積/血藥濃度-時(shí)間曲線下面積ARGNB=antibiotic-resistantgram-negativebacilli耐藥革蘭陰性桿菌ARMAnyofthetreatmentgroupsinarandomizedtrial.組arrhythmia心律不齊arsenicals=arseniccompounds砷化合物artificialdiscs人造脊椎artificialheartvalve人工心臟瓣膜artificialpancreas人工胰臟AS=ankylosingspondylitis強(qiáng)直性脊柱炎ASCO=AmericanSocietyofClinicalOncology美

21、國(guó)臨床腫瘤學(xué)會(huì)ASD=atrialseptaldefect房間隔缺損asepticpackaging無(wú)菌包裝AsianHarmonizationWorkingParty=AHWP醫(yī)療器械法規(guī)亞洲協(xié)調(diào)會(huì)aspartateaminotransferase=ASTLowlevelsofASTarenormallyfoundintheblood.Whenbodytissueoranorgansuchastheheartorliverisdiseasedordamaged,additionalASTisreleasedintothebloodstream.TheamountofASTintheblood

22、isdirectlyrelatedtotheextentofthetissuedamage.天門冬氨酸氨基轉(zhuǎn)移酶aspergillin曲霉菌素aspergillusflavus黃曲霉aspergillusochraceus赫曲霉ASR=alternativesummaryreportsassayconstancyCA檢驗(yàn)恒定性assaysensitiviyAS檢驗(yàn)靈敏度assistantinvestigator=AI助理研究者assuranceArenewablepermitgrantedbythefederalgovernmenttoaninstitutionorresearchcenter

23、toconductclinicaltrials.臨床試驗(yàn)許可AST=antimicrobialsusceptibilitytest藥敏試驗(yàn)=抗菌藥物敏感性試驗(yàn)AST=aspartateaminotransferase天門冬酸氨基轉(zhuǎn)換酶ASTMInternational(ASTM),originallyknownastheAmericanSocietyforTestingandMaterials美國(guó)材料與試驗(yàn)協(xié)會(huì)AstraZeneca阿斯利康as-treatedanalysisinanastreated(orobserveddata)analysisonlythosepatientsstillt

24、akingtheassignedtreatmentareanalyzed;thosewhodropoutarecensored.接受治療分析atopicdermatitis=AD異位性皮炎atorvastatin阿伐他汀系列cholesterol-loweringdrugATR=attenuatedtotalreflection衰減全反射法attenuatedtotalreflection=ATR衰減全反射法AUCss=areaundertheplasmaconcentration-timecurveatsteady-state穩(wěn)態(tài)血藥濃度時(shí)間曲線下面積audit指由不直接涉及試驗(yàn)的人員所進(jìn)行

25、的一種系統(tǒng)性檢查,以評(píng)價(jià)試驗(yàn)的實(shí)施、數(shù)據(jù)的記錄和分析是否與試驗(yàn)方案、標(biāo)準(zhǔn)操作規(guī)程以及藥物臨床試驗(yàn)相關(guān)法規(guī)要求相符稽查auditorinspection稽查視察auditreport稽查報(bào)告auditor稽查員autoimmunedisease,AID自身免疫病autologousmarrowstemcelltransplantation自體骨髓干細(xì)胞移植autologousstructuralcells自體結(jié)構(gòu)細(xì)胞AutomatedBrokerInterfaceoftheAutomatedCommercialSystem=ABI/ACS自動(dòng)商業(yè)系統(tǒng)下的自動(dòng)經(jīng)紀(jì)人界面AutomatedComme

26、rcialSystem自動(dòng)商業(yè)系統(tǒng)availabilityofwater有效水分Avandia(rosiglitazone)一種批準(zhǔn)用于治療2型糖尿病的藥物商品名:文迪雅;通用名:羅格列酮AventisPharma安萬(wàn)特醫(yī)藥averageconcentration/averageconcentrationvalue=Cav平均濃度B.Cereus=Bacilluscereus蠟狀芽孢桿菌B.atrophaeus草芽孢桿菌黑色變種bacilli芽孢桿菌Bacillusanthracis炭疽芽胞桿菌bacterialendospores細(xì)菌芽孢bacterialspore細(xì)菌孢子barcode條(

27、形)碼barbiturates巴比妥鹽basalmetabolicrate基礎(chǔ)代謝率baseline基線basiliximab(tradenameSimulect)舒萊;治療腎移植排斥藥batchproduction批量生產(chǎn);分批生產(chǎn)batchrelease批放行Baycol(cerivastatinsodium)拜斯亭;西立伐他汀;降血脂新藥BayerScheringPharma拜耳先靈醫(yī)藥BCGBostonConsultingGroup波士頓咨詢公司benchtest實(shí)驗(yàn)室試驗(yàn)benefit受益benzodiazepineBenzodiazepineshavealsobeenusedasa

28、daterapedrugbecausetheycanmarkedlyimpairandevenabolishfunctionsthatnormallyallowapersontoresistorevenwanttoresistsexualaggressionorassault苯重氮基鹽;苯二氮卓類抗焦慮藥本類藥物也稱弱安定藥,包括氯氮卓(利眠寧,chlordiazepoxide,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)及奧沙西泮(去甲羥基安定,舒寧,oxazepam)。臨床主要

29、用于鎮(zhèn)靜、催眠及對(duì)抗癲癇benzoicacid安息香酸BestPharmaceuticalsforChildrenAct2002最好的兒童醫(yī)藥品法案beta-blocker-受體阻滯劑Bextra(valdecoxib)伐地考昔(鎮(zhèn)痛類藥物)BfARM=BundesinstitutfrArzneimittelundMedizinprodukte德國(guó)聯(lián)邦藥品和醫(yī)療器械管理局BHC=BayerHealthCare拜耳醫(yī)藥保健有限公司bias指在設(shè)計(jì)臨床試驗(yàn)方案、執(zhí)行臨床試驗(yàn)、分析評(píng)價(jià)臨床試驗(yàn)結(jié)果時(shí),有關(guān)影響因素所致的系統(tǒng)誤差,致使療效或安全性評(píng)價(jià)偏離真值。偏倚bicohortstudy雙隊(duì)列研究b

30、ilirubin膽紅素BIMOBioresearchMonitoringProgram生物研究監(jiān)測(cè)bioavailability(F)expressionofhowmuchdrugreachesthecirculation(knowntopharmacologistsasthecentralcompartment)afteradministration生物利用度biochemicaldrugs生化藥品biocides生物殺滅劑;殺生物劑biocompatibilityThepropertyofbeingbiologicallycompatiblebynotproducingatoxic,inj

31、urious,orimmunologicalresponseinlivingtissue生物相容性;biodegradable生物分解bio-engineered,transgenicfood轉(zhuǎn)基因食物bioequivalence;bioequivalent(i.e.,performsinthesamemannerastheinnovatordrug生物等效biofilmAbiofilmisastructuredcommunityofmicroorganismsencapsulatedwithinaself-developedpolymericmatrixandadherenttoalivin

32、gorinertsurface細(xì)菌薄膜,生物膜biologicAvirus,therapeuticserum,toxin,antitoxin,vaccine,blood,bloodcomponentorderivative,allergenicproduct,oranalogousproductapplicabletotheprevention,treatmentorcureofdiseasesorinjuriesofman.biologicaltherapeuticagentsthatincludebloodandbloodproducts,vaccines,allergenics,cell

33、andtissue-basedproducts,andgenetherapyproducts生物制品biologicalresponsemodifiersBRMSubstancesthatstimulatethebodysresponsetoinfectionanddisease.Thebodynaturallyproducessmallamountsofthesesubstances.ScientistscanproducesomeoftheminthelaboratoryinlargeamountsforuseintreatingHYPERLINK/script/main/art.asp?

34、articlekey=13931cancer,HYPERLINK/script/main/art.asp?articlekey=466rheumatoidarthritis,andotherdiseases生物應(yīng)答調(diào)節(jié)劑biologicaltherapeuticagents生物治療藥劑biomarkerAbiochemicalfeatureorfacetthatcanbeusedtomeasuretheprogressofdiseaseortheeffectsoftreatment生物標(biāo)志物biometrics生物統(tǒng)計(jì);生物識(shí)別技術(shù)bionstimulator生物體刺激器bionicknee仿

35、生膝關(guān)節(jié)biopharma:biopharmaceuticalproducts生物藥物產(chǎn)品biosimilarBiosimilarsorFollow-onbiologicsaretermsusedtodescribeofficially-approvedsubsequentversionsofinnovatorbiopharmaceuticalproductsmadebyadifferentsponsorfollowingpatentandexclusivityexpiryontheinnovatorproduct.Biosimilarsarealsoreferredtoassubsequen

36、tentrybiologics(SEBs)inCanada生物類似物bipolar雙極燥郁癥birthdefect出生缺陷,新生兒缺陷,先天缺陷BLA=biologiclicenseapplication生物制品許可申請(qǐng)blankcontrol空白對(duì)照blenduniformityanalysis混合均勻度分析blindArandomizedtrialisBlindiftheparticipantisnottoldwhicharmofthetrialheison.AclinicaltrialisBlindifparticipantsareunawareonwhethertheyareinthe

37、experimentalorcontrolarmofthestudy;alsocalledmasked盲法blindcodes編制盲底blindreview在最后一份病例報(bào)告表輸入數(shù)據(jù)庫(kù)后,第一次揭盲之前對(duì)數(shù)據(jù)保持盲態(tài)的預(yù)分析審核,以便對(duì)統(tǒng)計(jì)分析計(jì)劃作最后的決定。盲態(tài)審核blindingmethod盲法blinding/masking盲法,設(shè)盲blisterpackaging泡罩包裝;水泡眼block分段;層blocksize每段的長(zhǎng)度blockedrandomization區(qū)組隨機(jī)bloodthinner血液稀釋藥bloodureanitrogen=BUN尿素氮BMP=bonemorphog

38、eneticproteins骨形成蛋白BMS(Bristol-MyersSquibb)百時(shí)美施貴寶公司BNF=biotechnologynotificationfile生物工程通報(bào)檔案BoardCertifiedrheumatologist美國(guó)國(guó)內(nèi)認(rèn)證的風(fēng)濕病學(xué)家BodyMassIndex=BMI體質(zhì)指數(shù)bolusamounts大劑量bonegrafting骨移植bonemarrowsuppression骨髓抑制botulinum肉毒桿菌botulism肉毒中毒boxedwarnings黑框警告brachytherapyseeds放射性粒子源近距離治療bradycardia心動(dòng)過(guò)緩breast

39、implants,Polyurethane-coated乳房植入物,聚亞安酯包囊;隆胸bromfenac溴酚酸BSE=BovineSpongiformEncephalopathy;madcowdisease瘋牛病;牛海綿狀腦病BU=BusinessUnits事業(yè)單位bubbleleaktest漏泄氣泡測(cè)試BUN=bloodureanitrogen尿素氮BureauofCustomsandBorderProtection=CBP美國(guó)海關(guān)與邊境保護(hù)局C.botulinum(proteolytic)=Clostridiumbotulinum肉毒梭狀芽孢桿菌(蛋白質(zhì)水解型)CABG=coronarya

40、rterybypassgraft冠狀動(dòng)脈旁路移植術(shù);冠狀動(dòng)脈搭橋手術(shù)CAGR=CompoundAnnualGrowthRate年均復(fù)合增長(zhǎng)率calciumantagonists鈣拮抗劑calciumchannelblockers=CCB鈣道阻滯劑calibration校準(zhǔn);標(biāo)定campylobacter彎曲桿菌campylobacterfetus胚胎彎曲桿菌campylobacterJejuni空腸彎桿菌cannulas套管CAP=correctiveactionplanbydrugsponsor糾正行動(dòng)計(jì)劃CAPA(Corrective&PreventiveAction)system糾正與預(yù)

41、防措施系統(tǒng)CapitationAflatmonthlyfeethatahealthplanpaystoaprovider(doctor,hospital,lab,etc.)totakecareofapatientsneeds.Capitationispartoftheprovider-reimbursementmechanism按人頭付費(fèi)carcinogenicriskassessment,proceduresfor致癌風(fēng)險(xiǎn)評(píng)估程序cardiacarrhythmia心律失常CardiacEP(electrophysiology)心臟電力生理cardiacresynchronizationthe

42、rapy心臟再同步化治療CarelinkMonitorCarelink監(jiān)護(hù)carryovereffect延滯效應(yīng)Carticel組織工程軟骨移植療法casehistory病歷caserecordform=CRF病例報(bào)告表/病例記錄表casereportform病例報(bào)告表cashcurve現(xiàn)金曲線cashtrap現(xiàn)金陷阱;現(xiàn)金套牢categoricalvariable分類變量catheters導(dǎo)管cathlabbypass導(dǎo)管室搭橋Cav平均濃度CBEsupplement“ChangesBeingEffected”supplement(FDA)“正在進(jìn)行修改”補(bǔ)充申請(qǐng)CBP(U.S.Custom

43、sandBorderProtection)美國(guó)海關(guān)與邊境保護(hù)局CCDSBoththeFDAandEMEAendorsetheuseofCCDSstotracksafetydataandsharelabelinginformation.TheEMEArequirescompaniestofilePeriodicSafetyUpdateReports(PSURs)regularlyandtheFDArequirespostmarketingreportsforsomedrugscurrentlyonthemarketandlikelymoreinthefuture=companycoredatas

44、heet公司核心數(shù)據(jù)表CCFAC=CodexCommitteeonFoodAdditivesandContaminants食品添加劑和污染物法典委員會(huì)CCFH=CodexCommitteeonFoodHygiene食品衛(wèi)生法典委員會(huì)CCT=controlledclinicaltrial對(duì)照臨床試驗(yàn)CD=circulardichroism圓二色譜CDER=CenterforDrugEvaluation&Research藥品審評(píng)和研究中心CDRamedicaltestingprotocolinwhichamedicineordrugisadministered,withdrawn,thenre-a

45、dministered,whilebeingmonitoredforadverseeffectsateachstage.Theprotocolisusedwhenstatisticaltestingisinappropriateduetoanidiosyncraticreactionbyaspecificindividual,oralackofsufficienttestsubjectsandunitofanalysisistheindividualChallenge-dechallenge-rechallenge給藥-停藥-再次給藥CDRH=CenterforDevicesandRadiol

46、ogicalHealth器械與輻射保健中心CEmark(anacronymfortheFrenchConformiteEuropeenne)certifiesthataproducthasmetEUhealth,safety,andenvironmentalrequirements,whichensureconsumersafetyCE認(rèn)證標(biāo)記Celebrex(celecoxib)西樂(lè)葆;COX2特異性抑制劑;塞來(lái)考昔CenterforBiologics,FoodandDrugAdministration生物制品中心CenterForFoodSafetyandAppliedNutrition=

47、CFSAN食品安全與應(yīng)用營(yíng)養(yǎng)中心CEP=CertificateofSuitabilitytotheMonographoftheEuropeanPharmacopoeia;CertificateofSuitabilitytotheEP歐洲藥典適應(yīng)性證書cephalosporins頭孢菌素類抗生素;cerebellaratrophy小腦萎縮cerebellarmalformation小腦畸形;小腦發(fā)育畸形cerebralinfarction腦梗塞Cerezyme伊米苷酶,治療罕見(jiàn)戈謝病(高雪氏病)CertificateofSuitabilitytotheEP(CEP)歐洲藥典適用性證書cetuxi

48、mab;Erbituxapprovedforcoloncancer,aswellasheadandneckcancer愛(ài)必妥CFG=CertificateforForeignGovernment致外國(guó)政府證書CFR=codeoffederalregulations(美國(guó))聯(lián)邦法規(guī);美國(guó)聯(lián)邦管理?xiàng)l例CFSAN=CenterForFoodSafetyandAppliedNutrition食品安全與應(yīng)用營(yíng)養(yǎng)中心CFU=colonyformingunit菌落形成單位cGMPs=currentgoodmanufacturingpractice現(xiàn)行生產(chǎn)質(zhì)量管理規(guī)范CGMS=continuousglucos

49、emonitoringsystem動(dòng)態(tài)血糖監(jiān)測(cè)Chagasdisease(alsocalledAmericantrypanosomiasis)美洲錐蟲病;恰加斯病Challenge-dechallenge-rechallenge=CDR給藥-停藥-再次給藥channelingbias渠道偏倚CHB=customshousebroker報(bào)關(guān)行chemotherapeuticsinseafood(aquaculturedrugresidues)藥Chi-squaretest/Chi-SquareGoodness-of-FitTest卡方檢驗(yàn)Child-PughChild-Pugh分級(jí)標(biāo)準(zhǔn)chlor

50、ambucil苯丁酸氮芥CHMP=CommitteeforMedicinalProductsforHumanUse人用藥品委員會(huì)cholestatichepatitis膽汁郁積型肝炎chromatography色譜chronicobstructivepulmonarydisease=COPD慢性阻塞性肺疾病ChronicWastingDisease(CWD)鹿慢性消耗性疾病CIOMS=CouncilforInternationalOrganizationsofMedicalSciences國(guó)際醫(yī)學(xué)科學(xué)組織委員會(huì)circulardichroismaformofspectroscopybasedo

51、nthedifferentialabsorptionofleft-andright-handedcircularlypolarizedlight.Itcanbeusedtohelpdeterminethestructureofmacromolecules(includingthesecondarystructureofproteinsandthehandednessofDNA).光學(xué)活性分子對(duì)左、右圓偏振光的吸收也不同,使左、右圓偏振光透過(guò)后變成橢圓偏振光,這種現(xiàn)象稱為圓二色性=CD圓二色譜;cirrhosis肝硬化citation傳喚CJD=Creutzfeld-Jakobdisease克-

52、雅病CL=clearancerate清除率claims宣示CleaningValidation清洗驗(yàn)證clearancerate=CL清除率cleftpalate腭裂CLIAClinicalLaboratoryImprovementAmendments臨床實(shí)驗(yàn)室改進(jìn)修訂案clinical(human)data臨床數(shù)據(jù)clinicalendpoint臨床終點(diǎn)clinicalequivalence臨床等效應(yīng)clinicalhold臨床試驗(yàn)暫停通知clinicalinvestigatorAmedicalresearcherinchargeofcarryingoutaclinicaltrialspro

53、tocol臨床研究者ClinicalPharmacists臨床藥師ClinicalResearchCoordinator=CRC臨床研究協(xié)調(diào)者clinicalstudy臨床研究ClinicalStudyApplication=CSA臨床研究申請(qǐng)clinicalstudyreport臨床試驗(yàn)的總結(jié)報(bào)告clinicaltrialAclinicaltrialisaresearchstudytoanswerspecificquestionsaboutvaccinesornewtherapiesornewwaysofusingknowntreatments.Clinicaltrials(alsocall

54、edmedicalresearchandresearchstudies)areusedtodeterminewhethernewdrugsortreatmentsarebothsafeandeffective.Carefullyconductedclinicaltrialsarethefastestandsafestwaytofindtreatmentsthatworkinpeople.Trialsareinfourphases:PhaseItestsanewdrugortreatmentinasmallgroup;PhaseIIexpandsthestudytoalargergroupofp

55、eople;PhaseIIIexpandsthestudytoanevenlargergroupofpeople;andPhaseIVtakesplaceafterthedrugortreatmenthasbeenlicensedandmarketed.臨床試驗(yàn)clinicaltrialapplication=CTA臨床試驗(yàn)申請(qǐng)clinicaltrialexemption=CTX臨床試驗(yàn)免責(zé)clinicaltrialprotocol=CTP臨床試驗(yàn)方案ClinicalTrialReport=CTR臨床試驗(yàn)報(bào)告clinicallysignificantresults有臨床意義closedloop

56、system閉路系統(tǒng)Clostridiumbotulinum肉毒桿菌Clostridiumsporogenes產(chǎn)孢梭菌;Cmax峰濃度CMC=chemistry,manufacturingandcontrol化學(xué)、生產(chǎn)和控制CMS=CentersforMedicare&MedicaidServices美國(guó)老年醫(yī)療保險(xiǎn)基金中心與窮人醫(yī)療救助基金服務(wù)中心CMS=ComplianceManagementSystem(拜耳醫(yī)藥保健有限公司的)規(guī)范管理系統(tǒng)CMS=ConcernedMemberStates有關(guān)成員國(guó)CMV=Cytomegalovirus巨細(xì)胞病毒CNSabnormalities中樞神經(jīng)系

57、統(tǒng)異常COA=certificateofanalysis分析證書co-administereddrug合并用藥;與其它藥物聯(lián)合使用coating涂層CodexAlimentarius國(guó)際食品法典委員會(huì)coexistentphysiologicalstate并存生理狀況COGS=Costofgoodssold主營(yíng)業(yè)務(wù)成本cohortInepidemiology,agroupofindividualswithsomecharacteristicsincommon隊(duì)列cohortstudies隊(duì)列研究co-investigator=CI合作研究者colonization(ofbacteria)寄殖c

58、olony-stimulatingfactors(CSF,GM-CSF,G-CSF)集落刺激因子colorectalcancer(CRC)結(jié)直腸癌combinationproduct復(fù)合產(chǎn)品combinationtherapy組合用藥;聯(lián)合用藥治療commercialrelease商業(yè)發(fā)行community-acquiredbacterialpneumonia社區(qū)獲得性細(xì)菌性肺炎community-basedclinicaltrial=CBCTAclinicaltrialconductedprimarilythroughprimary-carephysiciansratherthanacade

59、micresearchfacilities基于社區(qū)的臨床試驗(yàn)co-morbidcondition并存疾病;共患病COMP=CommitteeforOrphanMedicinalProducts罕用藥委員會(huì)comparison對(duì)照compassionateuseAmethodofprovidingexperimentaltherapeuticspriortofinalFDAapprovalforuseinhumans.Thisprocedureisusedwithverysickindividualswhohavenoothertreatmentoptions.體恤使用competitivela

60、beling優(yōu)越標(biāo)簽complementaryandalternativetherapyBroadrangeofhealingphilosophies,approaches,andtherapiesthatWestern(conventional)medicinedoesnotcommonlyusetopromotewell-beingortreathealthconditions.Examplesincludeacupuncture,herbs,etc.InternetAddress:補(bǔ)充性和非傳統(tǒng)治療completeresponse完全有效completeresponseletter完全回

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