藥物臨床試驗(yàn)常用英文

1、Accuracy準(zhǔn)確度Active control，AC陽性對(duì)照，活性對(duì)照Adverse drug reaction，ADR藥物不良反應(yīng)Adverse event，AE不良事件Adverse medical events不良醫(yī)學(xué)事件Adverse reaction藥物不良反應(yīng)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(zhuǎn)換酶Analysis sets統(tǒng)計(jì)分析的數(shù)據(jù)集Approval批準(zhǔn)Assistant investigator助理研究者AST天門冬酸氨基轉(zhuǎn)換酶ATR衰減全

2、反射法AUCss穩(wěn)態(tài)血藥濃度時(shí)間曲線下面積Audit稽查Audit or inspection稽查視察Audit report稽查報(bào)告Auditor稽查員Bias偏性，偏倚Bioequivalence生物等效應(yīng)Blank control空白對(duì)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(shè)盲Block分段Block層Block size每段的長(zhǎng)度BUN尿素氮Carryover effect延滯效應(yīng)Case history病歷Case report form病例報(bào)告表Cas

3、e report form/ case record form，CRF病例報(bào)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(yīng)Clinical study臨床研究Clinical study report臨床試驗(yàn)的總結(jié)報(bào)告Clinical trial臨床試驗(yàn)Clinical trial application，CTA臨床試驗(yàn)申請(qǐng)Clinical trial exemption，CTX臨床試驗(yàn)免責(zé)Clinical trial protocol，CTP臨床試驗(yàn)方案Clinical trial/ st

4、udy report臨床試驗(yàn)報(bào)告Cmax峰濃度Co-investigator合作研究者Comparison對(duì)照Compliance依從性Composite variable復(fù)合變量Computer-assisted trial design，CATD計(jì)算機(jī)輔助試驗(yàn)設(shè)計(jì)Confidence interval可信區(qū)間Confidence level置信水平Consistency test一致性檢驗(yàn)Contract research organization，CRO合同研究組織Contract/ agreement協(xié)議合同Control group對(duì)照組Coordinating committee協(xié)

5、調(diào)委員會(huì)Crea肌酐CRF（case report form）病例報(bào)告表Crossover design交叉設(shè)計(jì)Cross-over study交叉研究Css穩(wěn)濃度Cure痊愈Data management數(shù)據(jù)管理Database建立數(shù)據(jù)庫Descriptive statistical analysis描述性統(tǒng)計(jì)分析DF波動(dòng)系統(tǒng)Dichotomies二分類Diviation偏差Documentation記錄文件Dose-reaction relation劑量反應(yīng)關(guān)系Double blinding雙盲Double dummy雙模擬Double dummy technique雙盲雙模擬技術(shù)Doub

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

7、因設(shè)計(jì)Failure無效，失敗Final point終點(diǎn)Fixed-dose procedure固定劑量法Forced titration強(qiáng)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(zhì)譜聯(lián)用Generic drug通用名藥Global assessment variable全局評(píng)價(jià)變量GLU血糖Good clinical practice，GCP藥物臨床試驗(yàn)質(zhì)量管理規(guī)范Good manufacture practice，GMP藥品生產(chǎn)質(zhì)量管理規(guī)范Good non-clinical laboratory practice，GLP藥物非臨床研

8、究質(zhì)量管理規(guī)范Group sequential design成組序貫設(shè)計(jì)Health economic evaluation，HEV健康經(jīng)濟(jì)學(xué)評(píng)價(jià)Hypothesis test假設(shè)檢驗(yàn)Hypothesis testing假設(shè)檢驗(yàn)International Conference of Harmonization，ICH人用藥品注冊(cè)技術(shù)要求國(guó)際技術(shù)協(xié)調(diào)會(huì)，國(guó)際協(xié)調(diào)會(huì)議Improvement好轉(zhuǎn)Inclusion criteria入選標(biāo)準(zhǔn)Independent ethics committee，IEC獨(dú)立倫理委員會(huì)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(dòng)會(huì)議Inspection視察檢查Institution inspection機(jī)構(gòu)檢查Institution review board，IBR機(jī)構(gòu)審查委員會(huì)Intention to treat意向治療（臨床領(lǐng)域）Intention-totreat，ITT意向性分析（統(tǒng)計(jì)學(xué)）Interactive voice response system，IVRS互動(dòng)式語音應(yīng)答系統(tǒng)Interim analysis期中分析Investigator研究者Investigators brochure，IB研究

10、者手冊(cè)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(jié)轉(zhuǎn)LCMS液相色譜質(zhì)譜聯(lián)用LD50板數(shù)致死劑量Logic check邏輯檢查L(zhǎng)OQ（Limit of Quantitation）定量限LOCF，Last observation carry forward最近一次觀察的結(jié)轉(zhuǎn)Lost of follow up失訪Marketing approval/ authorization上市許可證Matched pair匹配配對(duì)Missing value缺失值Mixed effect model混合效應(yīng)模式Monitor監(jiān)查員Moni

11、toring監(jiān)查Monitoring report監(jiān)查報(bào)告MRT平均滯留時(shí)間MS質(zhì)譜MSMS質(zhì)譜質(zhì)譜聯(lián)用MTD（Maximum Tolerated Dose）最大耐受劑量Multicenter trial多中心試驗(yàn)Multi-center trial多中心試驗(yàn)New chemical entity，NCE新化學(xué)實(shí)體New drug application，NDA新藥申請(qǐng)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(jì)方法Obedience依從性O(shè)DR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(jié)果Outcome assessment結(jié)果指標(biāo)評(píng)價(jià)Outcome measurement結(jié)果指標(biāo)Outlier離群值Parallel group design平行組設(shè)計(jì)Parameter estimation參數(shù)估計(jì)Parametric statistics參數(shù)統(tǒng)計(jì)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(duì)照Polytomie

13、s多分類Power檢驗(yàn)效能Precision精密度Preclinical study臨床前研究Primary endpoint主要終點(diǎn)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(chǎn)品許可證Protocol試驗(yàn)方案Protocol試驗(yàn)方案Protocol amendment方案補(bǔ)正Quality assurance unit，QAU質(zhì)量保證部門Quality assurance，QA質(zhì)量保證Quality control，QC質(zhì)量控制Query lis

14、t，query form應(yīng)用疑問表Randomization隨機(jī)化Randomization隨機(jī)Range check范圍檢查Rating scale量表Regulatory authorities，RA監(jiān)督管理部門Replication可重復(fù)RSD日內(nèi)和日間相對(duì)標(biāo)準(zhǔn)差Run in準(zhǔn)備期Safety evaluation安全性評(píng)價(jià)Safety set安全性評(píng)價(jià)的數(shù)據(jù)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(biāo)Secondary variable次要變量Sequence試驗(yàn)次序Serio

15、us adverse event，SAE嚴(yán)重不良事件Serious adverse reaction，SAR嚴(yán)重不良反應(yīng)Seriousness嚴(yán)重性Severity嚴(yán)重程度Significant level檢驗(yàn)水準(zhǔn)Simple randomization簡(jiǎn)單隨機(jī)Single blinding單盲Single-blinding單盲Site audit試驗(yàn)機(jī)構(gòu)稽查SOP試驗(yàn)室的標(biāo)準(zhǔn)操作規(guī)程Source data verification，SDV原始數(shù)據(jù)核準(zhǔn)Source data，SD原始數(shù)據(jù)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(biāo)準(zhǔn)曲線Standard operating procedure，SOP標(biāo)準(zhǔn)操作規(guī)程Statistic統(tǒng)計(jì)量Statistical analysis plan統(tǒng)計(jì)分析計(jì)劃Statistical analysis plan統(tǒng)計(jì)參數(shù)計(jì)劃書Statistical analysis plan，SAP統(tǒng)計(jì)分析計(jì)劃Statistical model統(tǒng)計(jì)模型Statistical tables統(tǒng)計(jì)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(shí)別代碼Subject recruitment受試者招募Subject screening log受試者篩選表Superiority檢驗(yàn)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(biāo)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(shí)間TP總蛋白Transformation變量變換Treatment group試驗(yàn)組Trial error試驗(yàn)誤差Trial master file試驗(yàn)總檔案Trial obje