FDA詞匯說課材料

1、Good is good, but better carries it.精益求精，善益求善。FDA詞匯FDAGlossaryCompiledby:Yaw-TsongLeeLastupdated:December14,2013HYPERLINKltopTopHYPERLINKllawLaws&RegulationsHYPERLINKlFDAorgFDAOrganizationHYPERLINKlSFDAorgSFDA國食藥監(jiān)食品和藥物管理局局長瑪格麗特漢堡(MargaretHamburg)2-(4-hydroxyphenyl)acetamide2-（4-羥苯基）乙酰胺AAA=abdominala

2、orticaneurysm腹主動脈瘤ABCs=airways，breathing，circulation氣道、呼吸、循環(huán)ABI/ACS=AutomatedBrokerInterfaceoftheAutomatedCommercialSystem自動商業(yè)系統(tǒng)下的自動經(jīng)紀人界面(CBP的自動商業(yè)系統(tǒng))ABMS=AmericanBoardofMedicalSpecialities美國醫(yī)學(xué)專業(yè)委員會absorbablecollagensponge吸收性膠原海綿absorptionrateconstant/absorptionratecoefficientKa吸收速率常數(shù)/吸收速率系數(shù)abstinenc

3、esymptoms戒斷癥狀A(yù)cceleratedApprovalregulationallowingearlierapprovalofdrugstotreatseriousdiseases,andthatfillanunmetmedicalneedbasedonasurrogateendpoint.加速批準accesstomedicine(ATM)有藥品可使用ACCF=AmericanCollegeofCardiologyFoundation美國心臟病學(xué)會基金會accreditedschool備案，立案學(xué)校accuracy準確度Accutane,abrandofisotretinoin異維(生

4、素)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;醋氨酚;對乙酰(xian)氨基酚acidreflux胃酸逆流acidifiedfood酸化食品ACR-20improvementcriteria(AmericanCollegeofRheumatology)美國風(fēng)濕病學(xué)會類風(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ACSoftheBureauofCustomsandBor

5、derProtection(CBP)=AutomatedCommercialSystem自動商業(yè)系統(tǒng)ACTH=adrenocorticotropichormone促腎上腺皮質(zhì)激素Actimmune(Interferongamma-1b)abiologicresponsemodifier,isasingle-chainpolypeptidecontaining140aminoacids干擾素微克1bactionletter決定通知activecomparator活性對照藥物；活性藥物對照組activecontrol=AC陽性對照，活性對照；陽性藥activeingredient有效成分Activ

6、eSubstanceMasterFile(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)阿達木單抗adaptivedesign自適應(yīng)設(shè)計adaptiverandomization自適應(yīng)隨機ADE=adversedrugevent藥物不良事件adenoviralvectors腺病毒載體adequateandwell-controlledstudies充分嚴格的對照研究AD

7、HD=Attention-deficithyperactivitydisorder注意力缺陷多動障礙;注意力不足過動癥;多動癥adhesionbarrierproduct防黏著產(chǎn)品adjuvant助劑;佐劑auxiliary;adjuvanttherapy佐藥療法，輔助療法ADL=activitiesofdailyliving日常生活活動能力ADME=absorption,distribution,metabolism,andexcretion藥物的吸收、分布、代謝和排泄administrativedetention行政扣留權(quán)ADR=adversedrugreaction藥物不良反應(yīng)adren

8、alcortex腎上腺皮質(zhì)adrenalcorticalhormone腎上腺皮質(zhì)激素adrenalgland腎上腺adrenaline腎上腺素adrenoceptor腎上腺受體adrenocorticalsteroids腎上腺皮質(zhì)類固醇meadulterant摻雜物adulterateddevices摻假器械A(chǔ)dvaMed=AdvancedMedicalTechnologyAssociation,medicaltechnology(medicaldevices)tradeassociation先進醫(yī)療技術(shù)協(xié)會adventitiousinfectiousagents外來感染物adversedru

9、greaction=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(adverseevent)Anunwantedeffectcausedbytheadministrationofdrugs.Onsetmaybesuddenordevelopovertime藥物不良反應(yīng)advisory提醒advocacyandsupportgroupsOrganizationsandgroupsthatactivelysupportparticipantsandtheirfamilies

10、withvaluableresources,includingself-empowermentandsurvivaltools.倡導(dǎo)和支持團體AE=adverseeventAnegativeexperienceencounteredbyanindividualduringthecourseofaclinicaltrialthatisassociatedwiththedrug.不良事件AERS=AdverseEventReportingSystem;nowFDAAdverseEventReportingSystem(FAERS)不良事件報告系統(tǒng);aflatoxin黃曲霉素;黃曲霉毒素africa

11、nsleepingsickness非洲昏睡病;非洲錐蟲病AFSSAPS=AgenceFranaisedeScuritSanitairedesProduitsdeSant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aftereffect后遺效應(yīng)agency審理部門（指FDA）agonist興奮劑，激動劑，刺激物；競爭劑；拮抗劑AHA=AmericanHeartAssociation美國心臟病協(xié)會AIP=ApplicationIntegrityPolicyThebasicpremiseofAIPis:IfFDAdeterminesthatacompanysapplicationsarenotr

12、eliable,theagencywillnotperformsubstantivereviewofanyofthecompanysapplicationsuntilconfidenceinthedataisrestored.alsoFraudPolicy防偽政策airembolism氣體栓塞airhandling空氣處理airlock阻隔室alanineaminotransferase=ALTAnalanineaminotransferase(ALT)testmeasurestheamountofthisenzymeintheblood.ALTismeasuredtoseeifthelive

13、risdamagedordiseased.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近似致死劑量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堿性磷酸酶allergenicity致敏性allergi

15、cshock過敏性休克allogeneichematopoieticstemcell異基因造血干細胞allograftAnallograftisatransplantedorganortissuefromageneticallynon-identicalmemberofthesamespeciestransplantation同種異體移植ALOP=AppropriateLevelofProtection適當(dāng)?shù)谋Ｗo水平ALP=Alkalinephosphatase堿性磷酸酶alphaspendingfunction消耗函數(shù)ALS=amyotrophiclateralsclerosis;LouGe

16、hrigsDisease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;苯丙胺amyotrophiclateralsclerosis=ALS肌萎縮側(cè)索硬化ANAAtestforantinuclearantibodies(ANA)testiscommoninpeoplewhoaresuspectedofhavinganautoimmuneorco

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

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

19、orsomeofthevariability協(xié)變量分析analysissets統(tǒng)計分析的數(shù)據(jù)集analyte待測物anaphylaxis過敏性反應(yīng);過敏休克ANDA=abbreviatednewdrugapplication簡化新藥申請anginapectoris心絞痛angioplastyballoons血管修復(fù)氣囊animaltrial動物試驗anotia無耳;又稱“無耳畸形”antibioticprophylaxis預(yù)防性抗生素使用antibioticresistance抗生素抗性antihistamine抗組胺劑Anti-Infective抗感染藥物anti-inflammatorya

20、gents抗炎藥anti-metabolites抗代謝物;干擾代謝藥物antimicrobialresistance耐藥性anti-nutrients抗營養(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-TNFtherapy抗TNF-治療AORN=AssociationofPerioperativeRegisteredNurses美國圍手術(shù)注冊護士協(xié)會aorticdisease主動脈疾病aorticdissection主動脈夾層aorticste

21、nosis主動脈瓣狹窄APEC亞太經(jīng)濟合作組織APHIS=AnimalandPlantHealthInspectionService動植物衛(wèi)生檢驗局APIC=AssociationofProfessionalsofInfectionControlandEpidemiology美國感染控制和流行病專業(yè)協(xié)會APIs=activepharmaceuticalingredients/DrugSubstance(bulkdrugsubstances)原料藥/活性藥用成分aplasticanemia=pancytopenia再生障礙性貧血AppropriateLevelofProtection(ALOP)

22、適當(dāng)?shù)谋Ｗo水平approval批準approveddrugs已批準藥物approximatelethaldose=ALD近似致死劑量AnnualProductReviews(APR)年度產(chǎn)品審查aprotinin抑肽酶AQSIQ=ChinasGeneralAdministrationforQualitySupervision,InspectionandQuarantine國家質(zhì)量監(jiān)督檢驗檢疫總局;質(zhì)檢總局arachidonicacid花生四烯酸Arava=leflunomide愛若華（來氟米特）archivalcopy存檔用副本AreaUndertheCurve=AUC;areaunderth

23、eplasmaconcentration-timecurve藥時曲線下面積/血藥濃度-時間曲線下面積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arteryinfusion動脈滴注artificialdiscs人造脊椎artificialheartvalve人工心臟瓣膜artificialpancreas人工胰臟AS=ankylosingspondyl

24、itis強直性脊柱炎ASCO=AmericanSocietyofClinicalOncology美國臨床腫瘤學(xué)會ASD=atrialseptaldefect房間隔缺損asepticpackaging無菌包裝AsianHarmonizationWorkingParty=AHWP醫(yī)療器械法規(guī)亞洲協(xié)調(diào)會aspartateaminotransferase=ASTLowlevelsofASTarenormallyfoundintheblood.Whenbodytissueoranorgansuchastheheartorliverisdiseasedordamaged,additionalASTisre

25、leasedintothebloodstream.TheamountofASTinthebloodisdirectlyrelatedtotheextentofthetissuedamage.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檢驗恒定性assaysensitiviyAS檢驗靈敏度assistantinvestigator=AI助理研究者assuranceArenewablepermitgrantedbyth

26、efederalgovernmenttoaninstitutionorresearchcentertoconductclinicaltrials.臨床試驗許可AST=antimicrobialsusceptibilitytest藥敏試驗=抗菌藥物敏感性試驗AST=aspartateaminotransferase天門冬酸氨基轉(zhuǎn)換酶ASTMInternational(ASTM),originallyknownastheAmericanSocietyforTestingandMaterials美國材料與試驗協(xié)會AstraZeneca阿斯利康as-treatedanalysisinanastreat

27、ed(orobserveddata)analysisonlythosepatientsstilltakingtheassignedtreatmentareanalyzed;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-timecur

28、veatsteady-state穩(wěn)態(tài)血藥濃度時間曲線下面積audit指由不直接涉及試驗的人員所進行的一種系統(tǒng)性檢查，以評價試驗的實施、數(shù)據(jù)的記錄和分析是否與試驗方案、標準操作規(guī)程以及藥物臨床試驗相關(guān)法規(guī)要求相符稽查auditorinspection稽查視察auditreport稽查報告auditor稽查員autoimmunedisease,AID自身免疫病autologousmarrowstemcelltransplantation自體骨髓干細胞移植autologousstructuralcells自體結(jié)構(gòu)細胞AutomatedBrokerInterfaceoftheAutomatedComm

29、ercialSystem=ABI/ACS自動商業(yè)系統(tǒng)下的自動經(jīng)紀人界面AutomatedCommercialSystem自動商業(yè)系統(tǒng)autonomicneuropathy自主神經(jīng)病變availabilityofwater有效水分Avandia(rosiglitazone)一種批準用于治療2型糖尿病的藥物商品名：文迪雅；通用名：羅格列酮Avastin=Bevacizumab阿瓦斯丁;抗血管內(nèi)皮生長因子單克隆嵌合抗體AventisPharma安萬特醫(yī)藥averageconcentration/averageconcentrationvalue=Cav平均濃度B.Cereus=Bacilluscer

30、eus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細菌芽孢bacterialspore細菌孢子barcode條(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BayerSchering

31、Pharma拜耳先靈醫(yī)藥BCGBostonConsultingGroup波士頓咨詢公司benchtest實驗室試驗benefit受益benzodiazepineBenzodiazepineshavealsobeenusedasadaterapedrugbecausetheycanmarkedlyimpairandevenabolishfunctionsthatnormallyallowapersontoresistorevenwanttoresistsexualaggressionorassault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，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)及奧沙西泮(去甲羥基安定，舒寧，oxazepam)。臨床主要用于鎮(zhèn)靜、催眠及對抗癲癇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德國聯(lián)邦藥品和醫(yī)療器械管理

33、局BHC=BayerHealthCare拜耳醫(yī)藥保健有限公司bias指在設(shè)計臨床試驗方案、執(zhí)行臨床試驗、分析評價臨床試驗結(jié)果時，有關(guān)影響因素所致的系統(tǒng)誤差，致使療效或安全性評價偏離真值。偏倚bicohortstudy雙隊列研究bilirubin膽紅素BIMOBioresearchMonitoringProgram生物研究監(jiān)測bioavailability(F)expressionofhowmuchdrugreachesthecirculation(knowntopharmacologistsasthecentralcompartment)afteradministration生物利用度bioc

34、hemicaldrugs生化藥品biocides生物殺滅劑;殺生物劑biocompatibilityThepropertyofbeingbiologicallycompatiblebynotproducingatoxic,injurious,orimmunologicalresponseinlivingtissue生物相容性;biodegradable生物分解bio-engineered,transgenicfood轉(zhuǎn)基因食物bioequivalence;bioequivalenti.e.,performsinthesamemannerastheinnovatordrug生物等效biofilm

35、Abiofilmisastructuredcommunityofmicroorganismsencapsulatedwithinaself-developedpolymericmatrixandadherenttoalivingorinertsurface細菌薄膜,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生物應(yīng)答調(diào)節(jié)劑biologicaltherapeuticagents生物治療藥劑biomarkerAbiochemicalfeatureorfacetthatcanbe

38、usedtomeasuretheprogressofdiseaseortheeffectsoftreatment生物標志物biometrics生物統(tǒng)計;生物識別技術(shù)bionstimulator生物體刺激器bionicknee仿生膝關(guān)節(jié)biopharma:biopharmaceuticalproducts生物藥物產(chǎn)品biosimilarBiosimilarsorFollow-onbiologicsaretermsusedtodescribeofficially-approvedsubsequentversionsofinnovatorbiopharmaceuticalproductsmadeby

39、adifferentsponsorfollowingpatentandexclusivityexpiryontheinnovatorproduct.Biosimilarsarealsoreferredtoassubsequententrybiologics(SEBs)inCanada生物仿制藥，生物類似物，生物擬似物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blankcontrol空白對照blenduniformityanalysis混合過程是固體制劑生產(chǎn)的重要環(huán)節(jié)，對于保證制劑活性成

40、分分布均勻、質(zhì)量長期穩(wěn)定具有重要意義。混合不充分將導(dǎo)致藥品質(zhì)量嚴重不均一，而混合過久則是不必要的浪費能源混合均勻度分析blindArandomizedtrialisBlindiftheparticipantisnottoldwhicharmofthetrialheison.AclinicaltrialisBlindifparticipantsareunawareonwhethertheyareintheexperimentalorcontrolarmofthestudy;alsocalledmasked盲法blindcodes編制盲底blindreview在最后一份病例報告表輸入數(shù)據(jù)庫后，第一

41、次揭盲之前對數(shù)據(jù)保持盲態(tài)的預(yù)分析審核，以便對統(tǒng)計分析計劃作最后的決定。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每段的長度blockedrandomization區(qū)組隨機bloodbiochemistry血生化bloodthinner血液稀釋藥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）百時美施貴寶公司BNF=biotechnologynotificationfile生物工程通報檔案BoardCertified?？普J證BoardCertifiedrheumatologist美國?？普J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brachytherapy

44、seeds放射性粒子源近距離治療bradycardia心動過緩BreakthroughTherapyDesignationThisnewdesignationhelpsFDAassistdrugdeveloperstoexpeditethedevelopmentandreviewofnewdrugswithpreliminaryclinicalevidencethatindicatesthedrugmayofferasubstantialimprovementoveravailabletherapiesforpatientswithseriousorlife-threateningdiseas

45、es突破性療法認定breastimplants,Polyurethane-coated乳房植入物,聚亞安酯包囊;隆胸bromfenac溴xi酚酸BSE=BovineSpongiformEncephalopathy;madcowdisease瘋牛病;牛海綿狀腦病BsUFA(BiosimilarUserFeeAct)生物相似藥品用戶費用法BU=BusinessUnits事業(yè)單位bubbleleaktest漏泄氣泡測試BUN=bloodureanitrogen尿素氮BureauofCustomsandBorderProtection=CBP美國海關(guān)與邊境保護局C.botulinum(proteoly

46、tic)=Clostridiumbotulinum肉毒梭狀芽孢桿菌（蛋白質(zhì)水解型）CABG=coronaryarterybypassgraft冠狀動脈旁路移植術(shù);冠狀動脈搭橋手術(shù)CAGR=CompoundAnnualGrowthRate年均復(fù)合增長率calciumantagonists鈣拮抗劑calciumchannelblockers=CCB鈣道阻滯劑calibration校準;標定campylobacter彎曲桿菌campylobacterfetus胚胎彎曲桿菌campylobacterJejuni空腸彎桿菌cannulas套管CAP=correctiveactionplanbydrugs

47、ponsor糾正行動計劃CAPA(Corrective&PreventiveAction)system糾正與預(yù)防措施系統(tǒng)CapitationAflatmonthlyfeethatahealthplanpaystoaprovider(doctor,hospital,lab,etc.)totakecareofapatientsneeds.Capitationispartoftheprovider-reimbursementmechanism按人頭付費carcinogenicriskassessment,proceduresfor致癌風(fēng)險評估程序cardiacarrhythmia心律失常Cardia

48、cEP(electrophysiology)心臟電力生理cardiacresynchronizationtherapy心臟再同步化治療CarelinkMonitorCarelink監(jiān)護carryovereffect延滯效應(yīng)Carticel組織工程軟骨移植療法cartilagematrix軟骨基質(zhì)casehistory病歷caserecordform=CRF病例報告表/病例記錄表casereportform病例報告表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CB

49、C=completebloodcount血常規(guī)CBEsupplement“ChangesBeingEffected”supplement(FDA)“正在進行修改”補充申請CBP(U.S.CustomsandBorderProtection)美國海關(guān)與邊境保護局CCDSBoththeFDAandEMEAendorsetheuseofCCDSstotracksafetydataandsharelabelinginformation.TheEMEArequirescompaniestofilePeriodicSafetyUpdateReports(PSURs)regularlyandtheFDAre

50、quirespostmarketingreportsforsomedrugscurrentlyonthemarketandlikelymoreinthefuture=companycoredatasheet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CCFH=CodexCommitteeonFoodHygiene食品衛(wèi)生法典委員會CCT=controlledclinicaltrial對照臨床試驗CCyRoccursinthetreatmentofCMLwhencytogenetictestingi

51、sunabletodetectthePhiladelphia(Ph)chromosomeinbonemarroworbloodcells(0%Ph+cells)=completecytogeneticresponse細胞遺傳學(xué)完全應(yīng)答CD=circulardichroism圓二色譜CDER=CenterforDrugEvaluation&Research藥品審評和研究中心CDRamedicaltestingprotocolinwhichamedicineordrugisadministered,withdrawn,thenre-administered,whilebeingmonitoredf

52、oradverseeffectsateachstage.Theprotocolisusedwhenstatisticaltestingisinappropriateduetoanidiosyncraticreactionbyaspecificindividual,oralackofsufficienttestsubjectsandunitofanalysisistheindividualChallenge-dechallenge-rechallenge給藥-停藥-再次給藥CDRH=CenterforDevicesandRadiologicalHealth器械與輻射保健中心CEmark(anac

53、ronymfortheFrenchConformiteEuropeenne)certifiesthataproducthasmetEUhealth,safety,andenvironmentalrequirements,whichensureconsumersafetyCE認證標記Celebrex(celecoxib)西樂葆；COX2特異性抑制劑;塞來考昔cellbank細胞庫cellline細胞株censoring【統(tǒng)計】-刪截CenterforBiologics,FoodandDrugAdministration生物制品中心CenterForFoodSafetyandAppliedNutr

54、ition=CFSAN食品安全與應(yīng)用營養(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,治療罕見戈謝病(高雪氏病)CertificateofSuitabilitytotheEP(CEP)歐洲藥典適用性證書

55、cetuximab;Erbituxapprovedforcoloncancer,aswellasheadandneckcancer愛必妥CFG=CertificateforForeignGovernment致外國政府證書CFR=codeoffederalregulations（美國）聯(lián)邦法規(guī);美國聯(lián)邦管理條例CFSAN=CenterForFoodSafetyandAppliedNutrition食品安全與應(yīng)用營養(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=continuous

56、glucosemonitoringsystem動態(tài)血糖監(jiān)測Chagasdisease(alsocalledAmericantrypanosomiasis)美洲錐蟲病;恰加斯病Challenge-dechallenge-rechallenge=CDR給藥-停藥-再次給藥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報關(guān)行chemotherapeuticsinseafood(aquaculturedrugresidues)藥Child-PughChild-Pugh分級標準Chi-squaretest/Chi-SquareGoodness-of-FitTest卡方檢驗chlorambucil苯丁酸氮芥CHMP=CommitteeforMedicinalProductsforHumanUse人用藥品委員會cholestatichepatitis膽汁郁積型肝炎Cholestyramine考來烯胺CHR=Completehematologicresponseoccursinthetr

60、eatmentofCMLwhenbloodcellcountsreturntonormal,therearenoimmaturecellsvisibleintheblood,andthespleenreturnstonormalsize血液學(xué)完全應(yīng)答chromatography色譜chronicmyelocyticleukemia,chronicgranulocyticleukemia,CML,CGL慢性粒細胞白血病chronicobstructivepulmonarydisease=COPD慢性阻塞性肺疾病ChronicWastingDisease(CWD)鹿慢性消耗性疾病CIOMS=Cou