藥物臨床試驗常用英文

1、Accuracy準確度Active control，AC陽性對照，活性對照Adverse drug reaction，ADR藥物不良反應Adverse event，AE不良事件Adverse medical events不良醫(yī)學事件Adverse reaction藥物不良反應Alb白蛋白ALD（Approximate Lethal Dose）近似致死劑量ALP堿性磷酸酶Alpha spending function消耗函數(shù)ALT丙氨酸氨基轉換酶Analysis sets統(tǒng)計分析的數(shù)據集Approval批準Assistant investigator助理研究者AST天門冬酸氨基轉換酶ATR衰減全

2、反射法AUCss穩(wěn)態(tài)血藥濃度時間曲線下面積Audit稽查Audit or inspection稽查視察Audit report稽查報告Auditor稽查員Bias偏性，偏倚Bioequivalence生物等效應Blank control空白對照Blind codes編制盲底Blind review盲態(tài)審核Blind review盲態(tài)檢查Blinding method盲法Blinding/ masking盲法，設盲Block分段Block層Block size每段的長度BUN尿素氮Carryover effect延滯效應Case history病歷Case report form病例報告表Cas

3、e report form/ case record form，CRF病例報告表，病例記錄表Categorical variable分類變量Cav平均濃度CD圓二色譜CL清除率Clinical equivalence臨床等效應Clinical study臨床研究Clinical study report臨床試驗的總結報告Clinical trial臨床試驗Clinical trial application，CTA臨床試驗申請Clinical trial exemption，CTX臨床試驗免責Clinical trial protocol，CTP臨床試驗方案Clinical trial/ st

4、udy report臨床試驗報告Cmax峰濃度Co-investigator合作研究者Comparison對照Compliance依從性Composite variable復合變量Computer-assisted trial design，CATD計算機輔助試驗設計Confidence interval可信區(qū)間Confidence level置信水平Consistency test一致性檢驗Contract research organization，CRO合同研究組織Contract/ agreement協(xié)議合同Control group對照組Coordinating committee協(xié)

5、調委員會Crea肌酐CRF（case report form）病例報告表Crossover design交叉設計Cross-over study交叉研究Css穩(wěn)濃度Cure痊愈Data management數(shù)據管理Database建立數(shù)據庫Descriptive statistical analysis描述性統(tǒng)計分析DF波動系統(tǒng)Dichotomies二分類Diviation偏差Documentation記錄文件Dose-reaction relation劑量反應關系Double blinding雙盲Double dummy雙模擬Double dummy technique雙盲雙模擬技術Doub

6、le-blinding雙盲Drop out脫落DSC差示掃描熱量計Effectiveness療效Electronic data capture，EDC電子數(shù)據采集系統(tǒng)Electronic data processing，EDP電子數(shù)據處理系統(tǒng)Emergency envelope應急信件End point終點Endpoint criteria/ measurement終點指標Equivalence等效性Essential documentation必須文件Ethics committee倫理委員會Excellent顯效Exclusion criteria排除標準Factorial design析

7、因設計Failure無效，失敗Final point終點Fixed-dose procedure固定劑量法Forced titration強制滴定Full analysis set全分析集GCFTIR氣相色譜傅利葉紅外聯(lián)用GCMS氣相色譜質譜聯(lián)用Generic drug通用名藥Global assessment variable全局評價變量GLU血糖Good clinical practice，GCP藥物臨床試驗質量管理規(guī)范Good manufacture practice，GMP藥品生產質量管理規(guī)范Good non-clinical laboratory practice，GLP藥物非臨床研

8、究質量管理規(guī)范Group sequential design成組序貫設計Health economic evaluation，HEV健康經濟學評價Hypothesis test假設檢驗Hypothesis testing假設檢驗International Conference of Harmonization，ICH人用藥品注冊技術要求國際技術協(xié)調會，國際協(xié)調會議Improvement好轉Inclusion criteria入選標準Independent ethics committee，IEC獨立倫理委員會Information consent form，ICF知情同意書Informatio

9、n gathering信息收集Informed consent，IC知情同意Initial meeting啟動會議Inspection視察檢查Institution inspection機構檢查Institution review board，IBR機構審查委員會Intention to treat意向治療（臨床領域）Intention-totreat，ITT意向性分析（統(tǒng)計學）Interactive voice response system，IVRS互動式語音應答系統(tǒng)Interim analysis期中分析Investigator研究者Investigators brochure，IB研究

10、者手冊IR紅外吸收光譜Ka吸收速率常Last observation carry forward，LOCF最接近一次觀察的結轉LCMS液相色譜質譜聯(lián)用LD50板數(shù)致死劑量Logic check邏輯檢查LOQ（Limit of Quantitation）定量限LOCF，Last observation carry forward最近一次觀察的結轉Lost of follow up失訪Marketing approval/ authorization上市許可證Matched pair匹配配對Missing value缺失值Mixed effect model混合效應模式Monitor監(jiān)查員Moni

11、toring監(jiān)查Monitoring report監(jiān)查報告MRT平均滯留時間MS質譜MSMS質譜質譜聯(lián)用MTD（Maximum Tolerated Dose）最大耐受劑量Multicenter trial多中心試驗Multi-center trial多中心試驗New chemical entity，NCE新化學實體New drug application，NDA新藥申請NMR核磁共振譜Non-clinical study非臨床研究Non-inferiority非劣效性Non-parametric statistics非參數(shù)統(tǒng)計方法Obedience依從性ODR旋光光譜Open-blinding

12、非盲Open-label非盲Optional titration隨意滴定Original medical record原始醫(yī)療記錄Outcome結果Outcome assessment結果指標評價Outcome measurement結果指標Outlier離群值Parallel group design平行組設計Parameter estimation參數(shù)估計Parametric statistics參數(shù)統(tǒng)計方法Patient file病人檔案Patient history病歷Per protocol，PP符合方案集Placebo安慰劑Placebo control安慰劑對照Polytomie

13、s多分類Power檢驗效能Precision精密度Preclinical study臨床前研究Primary endpoint主要終點Primary variable主要變量Principal investigator主要研究者Principle investigator，PI主要研究者Product license，PL產品許可證Protocol試驗方案Protocol試驗方案Protocol amendment方案補正Quality assurance unit，QAU質量保證部門Quality assurance，QA質量保證Quality control，QC質量控制Query lis

14、t，query form應用疑問表Randomization隨機化Randomization隨機Range check范圍檢查Rating scale量表Regulatory authorities，RA監(jiān)督管理部門Replication可重復RSD日內和日間相對標準差Run in準備期Safety evaluation安全性評價Safety set安全性評價的數(shù)據集Sample size樣本含量Sample size樣本量，樣本大小Scale of ordered categorical ratings有序分類指標Secondary variable次要變量Sequence試驗次序Serio

15、us adverse event，SAE嚴重不良事件Serious adverse reaction，SAR嚴重不良反應Seriousness嚴重性Severity嚴重程度Significant level檢驗水準Simple randomization簡單隨機Single blinding單盲Single-blinding單盲Site audit試驗機構稽查SOP試驗室的標準操作規(guī)程Source data verification，SDV原始數(shù)據核準Source data，SD原始數(shù)據Source document，SD原始文件Specificity特異性Sponsor申辦者Sponsor-

16、investigator申辦研究者Standard curve標準曲線Standard operating procedure，SOP標準操作規(guī)程Statistic統(tǒng)計量Statistical analysis plan統(tǒng)計分析計劃Statistical analysis plan統(tǒng)計參數(shù)計劃書Statistical analysis plan，SAP統(tǒng)計分析計劃Statistical model統(tǒng)計模型Statistical tables統(tǒng)計分析表Stratified分層Study audit研究稽查Subgroup亞組Sub-investigator助理研究者Subject受試者Subje

17、ct diary受試者日記Subject enrollment受試者入選Subject enrollment log受試者入選表Subject identification code，SIC受試者識別代碼Subject recruitment受試者招募Subject screening log受試者篩選表Superiority檢驗Survival analysis生存分析SXRD單晶X射線衍射System audit系統(tǒng)稽查T1/2消除半衰期Target variable目標變量TBIL總膽紅素TCHO總膽固醇TG熱重分析TLC、HPLC制備色譜Tmax峰時間TP總蛋白Transformation變量變換Treatment group試驗組Trial error試驗誤差Trial master file試驗總檔案Trial obje