药物临床试验英文缩写2017

1、精选优质文档-倾情为你奉上精选优质文档-倾情为你奉上专心-专注-专业专心-专注-专业精选优质文档-倾情为你奉上专心-专注-专业常见缩略语集 TOC o 1-3 h z u 更新日期：2017年1月20日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

2、 the cure曲线下面积BMIBody Mass Index体质指数CATDComputer-assisted trial 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CTAC

3、linical Trial Application临床试验申请CTXClinical Trial Exemption临床试验免责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

4、据处理系统EMGElectromyography肌电图仪FASFull analysis set全分析集FDAFood 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IBInves

5、tigators Brochure研究者手册IBRInstitution review board机构审查委员会ICInformed 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

6、New Drug新药临床研究IRBInstitutional Review Board机构审查委员会ITTIntention-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 Welfa

7、re日本卫生福利部MIDASMigraine Disability Assessment偏头痛残疾程度评估问卷MSQMigraine-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

8、许可（申请）PPPer Protocol符合方案集PSIStatisticians in the Pharmaceutical 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/

9、文件SDSubject Diary受试者日记SFDAState Food and Drug Administration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 Operatin

10、g Procedure标准操作规程SPLStudy Personnel List研究人员名单SSSafety Analysis 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 Authorities

11、WHO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 report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

12、合作研究者Comparison对照Compliance依从性Composite variable复合变量Consistency 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 Documen

13、tation必需文件Ethics committee伦理委员会Excellent显效Exclusion criteria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 u

14、p失访MMonitor监察员Monitoring监查Monitoring Plan监察计划Monitoring Report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Pl

15、acebo安慰剂Placebo control安慰剂对照Preclinical study临床前研究Primary endpoint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

16、variable次要变量Sequence 试验次序Simple Randomization简单随机Single blinding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 enro

17、llment log受试者入选表Subject Identification Code List受试者识别代码表Subject 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

18、 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 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

19、corpusular volume平均红细胞体积MIDmid-value中值细胞MONOmonocytes单核细胞总数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

20、度WBCwhite blood cell 白细胞血生化-HBD-hydroxybutyric dehydrogenase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C3complemen

21、t C3补体C3C4complement C4补体C4Caserum calcium钙CHEcholinesterase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GSPgly

22、cated serum prot糖化血清蛋白HDL-Chigh-density lipoprotein cholesterol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 mag

23、nesium镁MTPmili-total protein微量蛋白MYOGmyoglobin肌红蛋白RFrheumatoid 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GLUgluco

24、se尿葡萄糖HPhigh power objective每高倍视野KETketone尿酮体LEUleucocyte尿白细胞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Pandypa

25、ndy庞氏试验乙肝标志物HBVhepatitis B virus乙肝病毒HBsAghepatitis B surface 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 immu

26、nosorbentassy酶联免疫吸附试验HAVhepatitis A virus甲肝病毒HCVhepatitis C 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 Reflec

27、tionATR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Carryover 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

28、统Dichotomies二分类Diviation偏差Dose-reaction relation剂量反应关系Double 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

29、 assessment variable全局评价变量Group sequential design成组序贯设计Health 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Maximum T