药物临床试验英文缩写2017(共13页).doc

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1、精选优质文档-倾情为你奉上常见缩略语集更新日期：2017年1月20日专心-专注-专业1、药物临床试验英文缩略语缩略语英文全称中文全称ACActive control阳性对照/活性对照ADEAdverse Drug Event药物不良事件ADRAdverse Drug Reaction药物不良反应AEAdverse Event不良事件AIAssistant Investigator助理研究者ALDApproximate Lethal Dose近似致死剂量AUCArea under the cure曲线下面积BMIBody Mass Index体质指数CATDComputer-assisted t

2、rial design 计算机辅助试验设计CICo-investigator合作研究者COICoordinating Investigator协调研究者CRCClinical Research Coordinator临床研究协调者CRFCase report form/ case record form病例报告表/病例记录表CROContract Research Organization合同研究组织CSAClinical Study Application临床研究申请CTAClinical Trial Application临床试验申请CTXClinical Trial Exemption临

3、床试验免责CTPClinical Trial Protocol临床试验方案CTRClinical Trial Report临床试验报告DASDisability assessment schedule功能残疾量表DSMBData Safety and monitoring Board数据安全及监控委员会ECGElectrocardiogram心电图EDCElectronic Data Capture电子数据采集系统EDPElectronic Data Processing电子数据处理系统EMGElectromyography肌电图仪FASFull analysis set全分析集FDAFood

4、 and Drug Administration美国食品与药品管理局FRFinal Report总结报告GASGlobal Assessment Scale总体评估量表GCPGood Clinical Practice药物临床试验质量管理规范GLPGood Laboratory Practice药物非临床试验质量管理规范GMPGood Manufacturing Practice药品生产质量管理规范HIT-6Headache Impact Test头痛影响测定问卷IBInvestigators Brochure研究者手册IBRInstitution review board机构审查委员会ICI

5、nformed Consent知情同意ICFInformed Consent Form知情同意书ICHInternational Conference on Harmonization国际协调会议IDMIndependent Data Monitoring独立数据监察IDMCIndependent Data Monitoring Committee独立数据监察委员会IECIndependent Ethics Committee独立伦理委员会INDInvestigational New Drug新药临床研究IRBInstitutional Review Board机构审查委员会ITTIntent

6、ion-to-treat意向性分析(统计学）IVDIn Vitro Diagnostic体外诊断IVRSInteractive Voice Response System互动语音应答系统IWRSinteractive web response system交互式网络响应系统MAMarketing Approval/Authorization上市许可证MCAMedicines Control Agency英国药品监督局MHWMinistry of Health and Welfare日本卫生福利部MIDASMigraine Disability Assessment偏头痛残疾程度评估问卷MSQM

7、igraine-Specific Quality of Life questionnaire偏头痛特异性生活质量问卷NDANew Drug Application新药申请NECNew Drug Entity新化学实体NIHNational Institutes of Health国家卫生研究所（美国）PIPrincipal Investigator主要研究者PLProduct License产品许可证PMAPre-market Approval (Application)上市前许可（申请）PPPer Protocol符合方案集PSIStatisticians in the Pharmaceut

8、ical Industry制药业统计学家协会QAQuality Assurance质量保证QCQuality Control质量控制RARegulatory Authorities监督管理部门SASite Assessment现场评估SAESerious Adverse Event严重不良事件SAPStatistical Analysis Plan统计分析计划SARSerious Adverse Reaction严重不良反应SDSource Data/Document原始数据/文件SDSubject Diary受试者日记SFDAState Food and Drug Administratio

9、n国家食品药品监督管理局SDVSource Data Verification原始数据核准SELSubject Enrollment Log受试者入选表SISub-investigator助理研究者SISponsor-Investigator申办研究者SICSubject Identification Code受试者识别代码SIGNScottish Intercollegiate Guidelines Network苏格兰会际指南网络标准SOPStandard Operating Procedure标准操作规程SPLStudy Personnel List研究人员名单SSSafety Anal

10、ysis Set安全分析集SSLSubject Screening Log受试者筛选表T&RTest and Reference Product受试和参比试剂UAEUnexpected Adverse Event预料外不良事件ULNUpper Limit Normal正常值上限WHOWorld Health Organization世界卫生组织WHO-ICDRAWHO International Conference of Drug Regulatory AuthoritiesWHO国际药品管理当局会议无缩略语AApproval批准Audit or inspection稽查视察Audit re

11、port稽查报告Auditor稽查员BBias偏性/偏倚Bioequivalence生物等效应Blank control空白对照Blind codes编制盲底Blind review盲态审核Blind review盲态检查Blinding method盲法Blinding/masking盲法/设盲CCase history病历Clinical equivalence临床等效应Clinical study临床研究Clinical trial临床试验Co-investigator 合作研究者Comparison对照Compliance依从性Composite variable复合变量Consist

12、ency test一致性检验Contract/ agreement协议合同Control group对照组Coordinating committee协调委员会DData management数据管理Documentation记录/文件Drop out脱落EEffectiveness疗效End point终点Endpoint Criteria终点指标Endpoint criteria/ measurement终点指标Equivalence等效性Essential Documentation必需文件Ethics committee伦理委员会Excellent显效Exclusion criteri

13、a排除标准FFailure无效/失败Final point终点IInclusion Criteria入选表准Inclusion criteria 入选标准Information Gathering信息收集Initial meeting启动会议Inspection检察/视察Institution inspection机构检查Interim analysis期中分析Investigational Product试验药物Investigator研究者LLost of follow up失访MMonitor监察员Monitoring监查Monitoring Plan监察计划Monitoring Rep

14、ort监察报告Multi-center Trial多中心试验NNon-clinical Study非临床研究Non-inferiority非劣效性OObedience依从性Open-label非盲Original medical record原始医疗记录Outcome结果Outcome Assessment结果评价Outcome assessment结果指标评价Outcome measurement结果指标PPatient file病人档案Patient history病历Placebo安慰剂Placebo control安慰剂对照Preclinical study临床前研究Primary e

15、ndpoint主要终点Primary variable主要变量Protocol试验方案Protocol Amendments修正案QQuery list query form应用疑问表RRandomization随机Reference Product参比制剂SSafety evaluation安全性评价Safety set安全性评价的数据集Sample size样本量样本大小Scale of ordered categorical ratings有序分类指标Secondary variable次要变量Sequence 试验次序Simple Randomization简单随机Single bli

16、nding单盲Site audit 试验机构稽查Standard operating procedure标准操作规程Sponsor申办者Sponsor-investigator申办研究者Study Audit研究稽查Study audit研究稽查Study Site研究中心Subgroup亚组Sub-investigator助理研究者Subject受试者Subject受试者Subject diary受试者日记Subject Enrollment受试者入选Subject enrollment log受试者入选表Subject Identification Code List受试者识别代码表Sub

17、ject Recruitment受试者招募Subject screening log受试者筛选表System audit系统稽查System Audit系统稽查TTest Product受试制剂Treatment group试验组Trial error试验误差Trial Initial Meeting试验启动会议Trial Master File试验总档案Trial objective试验目的Trial site试验场所Triple blinding三盲Two one-side test双单侧检验UUn-blinding揭盲2、血尿检查英文缩略语缩略语英文全称中文全称血常规ALallergy

18、lymphocyte变异淋巴细胞BASObasophilic granulocyte嗜碱性粒细胞EOSeosimophil嗜酸性粒细胞GRgranulocyte粒性白细胞HCThematocrit红细胞比积HGBhemoglobin血红蛋白LYMlymphocyte淋巴细胞MCHmean corpusular hemoglobin平均红细胞血红蛋白含量MCHCmean corpusular hemoglobin concerntration平均红细胞血红蛋白浓度MCVmean corpusular volume平均红细胞体积MIDmid-value中值细胞MONOmonocytes单核细胞总数

19、MPVmean platelet volume 平均血小板体积NEUneutrophilic granulocyte中性粒细胞PCTplateletocrit 血小板比积PDWplatelet distribution width 血小板分布宽度PLT/BPCplatelet count/blood platelet count血小板计数RBCred blood cell红细胞计数RDWred blood cell volume distribution width红细胞分布宽度WBCwhite blood cell 白细胞血生化-HBD-hydroxybutyric dehydrogenas

20、e羟丁酸脱氢酶a-AGa-acid glycoproteina酸性糖蛋白ALBalbumin白蛋白ALP/AKPalkaline phosphatase碱性磷酸酶ALTalanine amiotransferase丙氨酸氨基转移酶/谷丙转氨酶AMYserum amylase淀粉酶ASOantistreptolysin抗链球菌溶血素OASTaspartate aminotransferase门冬氨酸氨基转移酶/谷草转氨酶BUNusea nitrogen尿素氮C3complement C3补体C3C4complement C4补体C4Caserum calcium钙CHEcholinesteras

21、e胆碱酯酶CHOLcholesterol胆固醇CKcreatine kinase肌酸激酶CK-MBcreatine kinase-MB肌酸激酶同工酶CRE、Crcreatinine肌酐CRPC- reactive proteinC反应性蛋白cTNTtroponin T肌钙蛋白TDB/DBILdirect bilirubin直接胆红素-GT-glutamyl transpeptadase谷氨酰转肽酶/转肽酶GLOB/GLOglobulin球蛋白GLUglucose血糖GSPglycated serum prot糖化血清蛋白HDL-Chigh-density lipoprotein cholest

22、erol高密度脂蛋白IBILindirect bilirubin游离胆红素LDHlactate dehydrogenase乳酸脱氢酶LDL-Clow-density lipoprotein cholesterol低密度脂蛋白IgAimmunoglobin A免疫球蛋白AIgGimmunoglobin G免疫球蛋白GIgMimmunoglobin M免疫球蛋白MIPinorganic phosphate无机磷Lp(a)lipoprotein（a）脂蛋白（a）Mgserum magnesium镁MTPmili-total protein微量蛋白MYOGmyoglobin肌红蛋白RFrheumato

23、id factor类风湿因子TB/TBILtotal bilirubin总胆红素TBAtotal biliary acid总胆汁酸TGtriglyceride甘油三脂TPtotal protein总蛋白UA/URICuric acid尿酸UREAurea尿素VLDLvery low-density lipoprotein极低密度脂蛋白尿常规Addis countaddis count艾迪氏计数BILbilirubin尿胆红素BLDblood隐血/潜血BUN尿素氮GLUglucose尿葡萄糖HPhigh power objective每高倍视野KETketone尿酮体LEUleucocyte尿白

24、细胞LPlow power objective每低倍视野NITnitrite亚硝酸盐PHacidity尿酸碱度PROprotein尿蛋白OBoccult blood test大便隐血试验SGspecific gravity尿比重URO/UBGurobilinogen尿胆原WBCwhite blood cell白细胞电解质NaSodium钠Kkalium钾Clchloride氯Gacalcium钙Mgmagnesium镁体液常规CSFcerebrospinal脑积夜Pandypandy庞氏试验乙肝标志物HBVhepatitis B virus乙肝病毒HBsAghepatitis B surfac

25、e antigen乙肝表面抗原HBsAbantibody to hepatitis surface antigen乙肝表面抗体HBcAghepatitis B core antigen乙肝核心抗原HBcAbantibody to hepatitis B core antigen乙肝核心抗体HBeAghepatitis B e-antigen乙肝e抗原HBeAbantibody to hepatitis B e-antigen乙肝e抗体ELISAenzymelinked immunosorbentassy酶联免疫吸附试验HAVhepatitis A virus甲肝病毒HCVhepatitis C

26、 virus丙肝病毒输血免疫全套HBVhepatitis B virus乙型肝炎病毒HCVhepatitis C virus丙型肝炎病毒TPtreponema pallidum梅毒螺旋体HIVhuman immunodeficiency virus人类免疫缺陷病毒3、实验室英文缩略语英文全称缩略语中文全称Accuracy准确度Alb白蛋白Alpha spending function消耗函数Analysis sets统计分析的数据集Attenuated Total ReflectionATR衰减全反射法AUCss稳态血药浓度时间曲线下面积Block层Block size每段的长度Carryov

27、er effect延滞效应Categorical variable分类变量Cav平均浓度circular dichroismCD圆二色谱clearanceCL清除率Cmax峰浓度Confidence interval可信区间Confidence level置信水平Crossover design交叉设计Cross-over Study交叉研究Css稳浓度Cure痊愈Database建立数据库Descriptive statistical analysis描述性统计分析DF波动系统Dichotomies二分类Diviation偏差Dose-reaction relation剂量反应关系Doubl

28、e dummy双模拟Double dummy technique双盲双模拟技术Differential Scanning CalorimeterDSC差示扫描热量计Emergency envelope应急信件Factorial design析因设计Fixed-dose procedure固定剂量法Forced titration强制滴定Full analysis set全分析集GCFTIR气相色谱傅利叶红外联用GCMS气相色谱质谱联用Generic drug通用名药Global assessment variable全局评价变量Group sequential design成组序贯设计Heal

29、th economic evaluationHEV健康经济学评价Hypothesis test假设检验Hypothesis testing假设检验Improvement好转Last observation carry forwardLOCF最接近一次观察的结转LCMS液相色谱质谱联用Last observation carry forwardLOCF最近一次观察的结转Logic check逻辑检查Limit of QuantizationLOQ定量限Marketing approval/ authorization上市许可证Mass spectrumMS质谱Matched pair匹配配对Ma

30、ximum Tolerated DoseMTD最大耐受剂量Mean residence timeMRT平均滞留时间Median lethal doseLD50半数致死剂量Missing value缺失值Mixed effect model混合效应模式MS-MS质谱质谱联用New chemical entity NCE新化学实体New drug application NDA新药申请Nuclear Magnetic Resonance SpectroscopyNMR核磁共振谱Non-parametric statistics非参数统计方法Optical rotatory dispersionOR

31、D旋光光谱Optional titration随意滴定Outlier离群值Parallel group design平行组设计Parameter estimation参数估计Parametric statistics参数统计方法Polytomies多分类Power检验效能Precision精密度Range check范围检查Rating scale量表Replication可重复Relative stadard deviation,RSD日内和日间相对标准差Run in准备期Seriousness严重性Severity严重程度Severity严重程度Significant level检验水准S

32、pecificity特异性Standard curve标准曲线Statistic统计量Statistical analysis plan统计分析计划Statistical model统计模型Statistical tables统计分析表Stratified分层Superiority 检验Survival analysis生存分析SXRD单晶X射线衍射T1/2消除半衰期Target variable目标变量TG热重分析TLC、HPLC制备色谱Tmax峰时间TP总蛋白Transformation变量变换UVVIS紫外可见吸收光谱Variability变异Variable变量Visual analogy scale直观类比打分法Visual check人工检查Vulnerable subject弱势受试者Wash-out洗脱Washout period洗脱期