药物临床试验英文词汇及缩写

1、精品药物临床试验英文缩写缩略语英文全称中文全称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BMIBody Mass Index体质指数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病历报告表CROContract Research Organizatio

2、n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临床试验免责CTPClinical Trial Protocol临床试验方案CTRClinical Trial Report临床试验报告DSMBData Safety and monitoring Board数据安全及监控委员会EDCElectronic Data Capture电子数据采集系统EDPElectronic Data Processing电子数据处理系统FDAFood and

3、 Drug Administration美国食品与药品管理局FRFinal Report总结报告GCPGood Clinical Practice药物临床试验质量管理规范感谢下载载精品缩略语英文全称中文全称GCPGood 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IBInvestigators Brochure研究者手册ICInformed Consent知情同意ICFInformed Consent Form知情同意书ICHInternationalConferenceon国际协调会议Har

4、monizationIDMIndependent Data Monitoring独立数据监察IDMCIndependentDataMonitoring独立数据监察委员会CommitteeIECIndependent 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IVDIn Vitro Diagnostic体外诊断IVRSInteractive Voice Response System互动语音应答系统MAMarketing Approval/Authoriz

5、ation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主要研究者感谢下载载精品缩略语英文全称中文全称PLProduct License产品许可证PMAPre-market Approval (Application)上市前许可（申请）PSIStatis

6、ticiansin the Pharmaceutical制药业统计学家协会IndustryQAQuality 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 Fo

7、od 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SOPStandard Operating Procedure标准操作规程SPLStudy Personnel List研究人员名单SSLSubject Screening Log受试者筛选表感谢下载载精品缩略语英文全称中文

8、全称T&RTest and Reference Product受试和参比试剂UAEUnexpected Adverse Event预料外不良事件WHOWorld Health Organization世界卫生组织WHO-ICDRAWHO International Conference ofWHO 国际药品管理当局会议Drug Regulatory Authorities药物临床试验英文缩写英文全称中文全称Accuracy准确度Active control, AC阳性对照 活性对照Adverse drug reaction, ADR药物不良反应Adverse event, AE不良事件

9、Adverse medical events不良医学事件Adverse reaction药物不良反应Alb白蛋白ALD （ Approximate Lethal Dose）近似致死剂量感谢下载载精品英文全称中文全称ALP碱性磷酸酶Alpha spending function消耗函数ALT丙氨酸氨基转换酶Analysis sets统计分析的数据集Approval批准Assistant investigator助理研究者AST天门冬酸氨基转换酶ATR衰减全反射法AUCss稳态血药浓度时间曲线下面积Audit稽查Audit or inspection稽查视察Audit report稽查报告Audi

10、tor稽查员Bias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 /设盲感谢下载载精品英文全称中文全称Block层Block size每段的长度Carryover effect延滞效应Case history病历Case report form/ case record form CRF病例报告表病例记录表Categorical variable分类变量Cav平均浓度CD圆二色谱CL清除率Clin

11、ical equivalence临床等效应Clinical study临床研究Clinical study report临床试验的总结报告Clinical trial临床试验Clinical trial applicationCTA临床试验申请Clinical trial exemptionCTX临床试验免责Clinical trial protocol CTP临床试验方案Clinical trial/ study report临床试验报告Cmax峰浓度Co-investigator合作研究者Comparison对照Compliance依从性感谢下载载精品英文全称中文全称Composite v

12、ariable复合变量Computer-assisted trial design CATD计算机辅助试验设计Confidence interval可信区间Confidence level置信水平Consistency test一致性检验Contract research organization CRO合同研究组织Contract/ agreement协议合同Control group对照组Coordinating committee协调委员会Crea肌酐CRF(case report form)病例报告表Crossover design交叉设计Cross-over Study交叉研究Css

13、稳浓度Cure痊愈Data management数据管理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偏差感谢下载载精品英文全称中文全称Documentation记录文件Dose-reaction relation剂量反应关系Double dummy双模拟Double dummy technique双盲双模拟技术Drop out脱落DSC差示扫描热量计Effectiveness疗效Electronic data capture EDC电子数据采集系统Electronic data

14、 processing EDP电子数据处理系统Emergency envelope应急信件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 criteria排除标准Factorial design析因设计Failure无效失败Final point终点感谢下载载精品英文全称中文全称Fixed-dose procedure固定剂量法Forced tit

15、ration强制滴定Full analysis set全分析集GC FTIR气相色谱傅利叶红外联用GC MS气相色谱质谱联用Generic drug通用名药Global assessment variable全局评价变量GLU血糖Good clinical practice, GCP药物临床试验质量管理规范Good manufacture practice, GMP药品生产质量管理规范Goodnon-clinicallaboratorypractice,药物非临床研究质量管理规范GLPGroup sequential design成组序贯设计Health economic evaluation

16、, HEV健康经济学评价Hypothesis test假设检验Hypothesis testing假设检验Improvement好转Inclusion Criteria入选表准Inclusion criteria入选标准Independent ethics committeeIEC独立伦理委员会Information consent formICF知情同意书感谢下载载精品英文全称中文全称Information Gathering信息收集Informed consent IC知情同意Initial meeting启动会议Inspection检察 /视察Institution inspection

17、机构检查Institution review board, IBR机构审查委员会Intention-totreat ITT意向性分析 ( 统计学）Interactive voice response systemIVRS互动式语音应答系统Interim analysis期中分析InternationalConferenceof人用药品注册技术要求国际技术协调会国Harmonization ICH际协调会议Investigational Product试验药物Investigator研究者Investigators brochure, IB研究者手册Last observation carry

18、forward, LOCF最接近一次观察的结转LC MS液相色谱质谱联用LD50板数致死剂量LOCF, Last observation carry forward最近一次观察的结转Logic check逻辑检查LOQ (Limit of Quantization)定量限Lost of follow up失访感谢下载载精品英文全称中文全称Marketing approval/ authorization上市许可证Matched pair匹配配对Missing value缺失值Mixed effect model混合效应模式Monitor监察员Monitoring监查Monitoring Pla

19、n监察计划Monitoring Report监察报告MRT平均滞留时间MS质谱MS MS质谱质谱联用MTD （ Maximum Tolerated Dose）最大耐受剂量Multi-center Trial多中心试验New chemical entityNCE新化学实体New drug applicationNDA新药申请NMR核磁共振谱Non-clinical Study非临床研究Non-inferiority非劣效性Non-parametric statistics非参数统计方法Obedience依从性ODR旋光光谱感谢下载载精品英文全称中文全称Open-label非盲Optional t

20、itration随意滴定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Patient file病人档案Patient history病历Per protocolPP符合方案集Placebo安慰剂Placebo control安慰剂对照Polytomies多分

21、类Power检验效能Precision精密度Preclinical study临床前研究Primary endpoint主要终点感谢下载载精品英文全称中文全称Primary variable主要变量Principle investigatorPI主要研究者Product license PL产品许可证Protocol试验方案Protocol Amendments修正案Quality assurance QA质量保证Quality assurance unit QAU质量保证部门Quality control QC质量控制Query listquery form应用疑问表Randomizatio

22、n随机Range check范围检查Rating scale量表Reference Product参比制剂Regulatory authoritiesRA监督管理部门Replication可重复RSD日内和日间相对标准差Run in准备期Safety 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有序分类指标感谢下载载精品英文全称中文全称Secondary variable次要变量Sequence试验次序Serious adverse event SAE严重不良事件

23、Serious adverse reaction SAR严重不良反应Seriousness严重性Severity严重程度Severity严重程度Significant level检验水准Simple Randomization简单随机Single blinding单盲Site audit试验机构稽查SOP试验室的标准操作规程Source data SD原始数据Source data verification SDV原始数据核准Source document SD原始文件Specificity特异性Sponsor申办者Sponsor-investigator申办研究者Standard curve

24、标准曲线Standard operating procedureSOP标准操作规程Statistic统计量感谢下载载精品英文全称中文全称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 e

25、nrollment log受试者入选表Subject identification codeSIC受试者识别代码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Superiority检验Survival analysis生存分析SXRD单晶 X射线衍射感谢下载载精品英文全称中文全称System audit系统稽查System Audit系统稽查T1/2消除半衰期Target variable目标变量TBIL总胆红素TCHO总胆固醇Test Product受试制剂

26、TG热重分析TLC、 HPLC制备色谱Tmax峰时间TP总蛋白Transformation变量变换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Un-blinding揭盲感谢下载载精品英文全称中文全称Unexpected adverse eventUAE预料外不良事件UV VIS紫外可见吸收光谱Variability变异Variable

27、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洗脱期实验室检查英文缩写英文全称中文全称血常规WBC white blood cell count白细胞计数GR% granulocyte中性粒细胞百分比LY% lymphocyte淋巴细胞百分比MID%中值细胞百分比EOS% eosimophil嗜酸性粒细胞百分比感谢下载载精品英文全称中文全称AL% allergy lymphocyte变异淋巴细胞百分比ST%中性杆状粒细胞百分比RBC red blood ce

28、ll红细胞计数HGB hemoglobin血红蛋白HCT hematocrit红细胞比积红细胞比积MCV mean corpusular volume平均红细胞体积MCH mean corpusular hemoglobin平均红细胞血红蛋白含量MCHC mean corpusularhemoglobin平均红细胞血红蛋白浓度concerntrationRDW red blood cell volume distribution红细胞分布宽度变异widthPLT/BPC plateletcount/bloodplatelet血小板计数countMPV mean platelet volume平

29、均血小板体积PCT plateletocrit血小板比积PDW platelet distribution width血小板分布宽度尿便常规PH acidity酸碱度NIT nitrite亚硝酸盐GLU glucose尿糖SG specific gravity比重PRO protein尿蛋白感谢下载载精品英文全称中文全称BLD blood隐血BIL bilirubin尿胆红素URO urobilinogen尿胆原WBC white blood cell白细胞addish计数addish count艾迪氏计数/HP high power objective每高倍视野/LP low power o

30、bjective每低倍视野OB occult blood test大便隐血试验体液常规CSF cerebrospinal脑积夜Pandy pandy庞氏试验生化检验TB total bilirubin总胆红素DB direct bilirubin直接胆红素TP total protein总蛋白ALB albumin白蛋白GLOB globulin球蛋白UREA urea尿素CREA creatinine肌肝UA uric acid尿酸GLU glucose血糖ALT alanine amiotransferase丙氨酸氨基转移酶感谢下载载精品英文全称中文全称AST aspartate amin

31、otransferase门冬氨酸氨基转移酶GGT-glutamyl transpeptadase谷氨酰转肽酶CK creatine kinase肌酸肌酶CK-MB creatine kinase-MB肌酸肌酶同工酶LDH lactate dehydrogenase乳酸脱氢酶-HBD-hydroxybutyric羟丁酸脱氢酶dehydrogenaseAMY serum amylase血淀粉酶TG triglyceride肝油三脂CHOL cholesterol胆固醇HDL-chigh-densitylipoprotein高密度脂蛋白cholesterolLDL-clow-densitylipop

32、rotein低密度脂蛋白cholesterolVLDL very low-density lipoprotein极低密度脂蛋白Ca serum calcium钙Mg serum magnesium镁IP inorganic phosphate无机磷ALP alkaline phosphatase碱性磷酸酶TBA total biliary acid总胆汁酸ASO antistreptolysin抗链球菌溶血素 Oa-AG a acid glycoproteina酸性糖蛋白感谢下载载精品英文全称中文全称CRP C-reactive protein C反应蛋白RF rheumatoid facto

33、r类风湿因子MTP mili-total protein微量蛋白IgG immunoglobin G免疫球蛋白GIgA immunoglobin A免疫球蛋白AIgM immunoglobin M免疫球蛋白MC3 complement C3补体 C3C4 complement C4补体 C4cTNT troponin T肌钙蛋白 TMYOG myoglobin肌红蛋白电解质Na sodium钠K kalium钾Cl chloride氯Ga calcium钙Mg magnesium镁乙肝标志物HBV hepatitis B virus乙肝病毒HBsAg hepatitis B surface a

34、ntigen乙肝表面抗原HBsAbantibodytohepatitissurface乙肝表面抗体antigenHBcAg hepatitis B core antigen乙肝核心抗原感谢下载载精品英文全称中文全称HBcAbantibodytohepatitisBcore乙肝核心抗体antigenHBeAg hepatitis B e-antigen乙肝 e 抗原HBeAb antibody to hepatitis B e-antigen乙肝 e 抗体ELISAenzymelinked酶联免疫吸附试验immunosorbentassyHAV hepatitis A virus甲肝病毒HCV

35、hepatitis C virus丙肝病毒输血免疫全套HBV hepatitis B virus乙型肝炎病毒HCV hepatitis C virus丙型肝炎病毒TP treponema pallidum梅毒螺旋体HIV human immunodeficiency virus人类免疫缺陷病毒Accuracy准确度Active control， AC 阳性对照，活性对照Adverse drug reaction， ADR 药物不良反应Adverse event， AE 不良事件Adverse medical events不良医学事件Adverse reaction药物不良反应Alb 白蛋白感谢

36、下载载精品ALD （ Approximate Lethal Dose） 近似致死剂量ALP 碱性磷酸酶Alpha spending function消耗函数ALT 丙氨酸氨基转换酶Analysis sets统计分析的数据集Approval批准Assistant investigator助理研究者AST 天门冬酸氨基转换酶ATR 衰减全反射法AUCss 稳态血药浓度时间曲线下面积Audit稽查Audit or inspection稽查视察Audit report稽查报告Auditor稽查员Bias 偏性，偏倚Bioequivalence生物等效应Blank control空白对照Blind co

37、des编制盲底Blind review盲态审核Blind review盲态检查Blinding method盲法感谢下载载精品Blinding/ masking盲法，设盲Block 分段Block 层Block size每段的长度BUN 尿素氮Carryover effect延滞效应Case history病历Case report form病例报告表Case report form/ case record form， CRF 病例报告表，病例记录表Categorical variable分类变量Cav 平均浓度CD 圆二色谱CL 清除率Clinical equivalence临床等效应Cl

38、inical study临床研究Clinical study report临床试验的总结报告Clinical trial临床试验Clinical trial application， CTA 临床试验申请Clinical trial exemption， CTX 临床试验免责Clinical trial protocol， CTP 临床试验方案Clinical trial/ study report临床试验报告感谢下载载精品Cmax 峰浓度Co-investigator合作研究者Comparison对照Compliance依从性Composite variable复合变量Computer-as

39、sisted trial design， CATD 计算机辅助试验设计Confidence interval可信区间Confidence level置信水平Consistency test一致性检验Contract research organization， CRO 合同研究组织Contract/ agreement协议合同Control group对照组Coordinating committee协调委员会Crea 肌酐CRF（ case report form） 病例报告表Crossover design交叉设计Cross-over study交叉研究Css 稳浓度Cure 痊愈Data

40、 management数据管理Database建立数据库感谢下载载精品Descriptive statistical analysis描述性统计分析DF 波动系统Dichotomies二分类Diviation偏差Documentation记录文件Dose-reaction relation剂量反应关系Double blinding双盲Double dummy双模拟Double dummy technique双盲双模拟技术Double-blinding双盲Drop out脱落DSC 差示扫描热量计Effectiveness疗效Electronic data capture， EDC 电子数据采集

41、系统Electronic data processing， EDP 电子数据处理系统Emergency envelope应急信件End point终点Endpoint criteria/ measurement终点指标Equivalence等效性Essential documentation必须文件Ethics committee伦理委员会感谢下载载精品Excellent显效Exclusion criteria排除标准Factorial design析因设计Failure无效，失败Final point终点Fixed-dose procedure固定剂量法Forced titration强制滴

42、定Full analysis set全分析集GC FTIR 气相色谱傅利叶红外联用GC MS 气相色谱质谱联用Generic drug通用名药Global assessment variable全局评价变量GLU 血糖Good clinical practice， GCP 药物临床试验质量管理规范Good manufacture practice， GMP 药品生产质量管理规范Good non-clinical laboratory practice， GLP 药物非临床研究质量管理规范Group sequential design成组序贯设计Health economic evaluation， HEV 健康经济学评价Hypothesis test假设检验Hypothesis testing假设检验感谢下载载精品International Confere