藥物臨床試驗英文縮寫2017120概述

1、常見縮略語集1、藥物臨床試驗英文縮寫 22 、血尿檢查英文縮寫 73 、實驗室英文縮寫 10更新日期： 2017年 1月 20日1、藥物臨床試驗英文縮略語縮略語英文全稱中文全稱ACActive con trol陽性對照/活性對照ADEAdverse Drug Eve nt藥物不良事件ADRAdverse Drug Reacti on藥物不良反應AEAdverse Eve nt不良事件AIAssista nt Inv estigator助理研究者ALDApproximate Lethal Dose近似致死劑量AUCArea un der the cure曲線下面積BMIBody Mass In

2、dex體質指數CATDComputer-assisted trial desig n計算機輔助試驗設計CICo-i nv estigator合作研究者COICoord in ati ng Inv estigator協調研究者CRCCli nical Research Coord in ator臨床研究協調者CRFCase report form/ case record form病例報告表/病例記錄表CROCon tract Research Orga ni zati on合同研究組織CSACli ni cal Study Applicati on臨床研究申請CTAClinical Trial

3、 Application臨床試驗申請CTXClinical Trial Exemption臨床試驗免責CTPCli nical Trial Protocol臨床試驗方案CTRCli nical Trial Report臨床試驗報告DASDisability assessme nt schedule功能殘疾量表DSMBData Safety and mon itor ing Board數據安全及監(jiān)控委員會ECGElectrocardiogram心電圖EDCElectro nic Data Capture電子數據米集系統EDPElectro nic Data Process ing電子數據處理系統

4、EMGElectromyography肌電圖儀FASFull an alysis set全分析集FDAFood and Drug Adm ini strati on美國食品與藥品管理局FRFinal Report總結報告GASGlobal Assessme nt Scale總體評估量表GCPGood Cli nical Practice藥物臨床試驗質量管理規(guī)范GLPGood Laboratory Practice藥物非臨床試驗質量管理規(guī)范GMPGood Manu facturi ng Practice藥品生產質量管理規(guī)范HIT-6Headache Impact Test頭痛影響測定問卷IBIn

5、vestigator s Brochure研究者手冊縮略語英文全稱中文全稱IBRIn stituti on review board機構審查委員會ICIn formed Consent知情同意ICFIn formed Consent Form知情同意書ICHIntern ati onal Conference on Harmoni zation國際協調會議IDMIn depe ndent Data Mon itori ng獨立數據監(jiān)察IDMCIndependent Data Monitoring Committee獨立數據監(jiān)察委員會IECIn depe ndent Ethics Committ

6、ee獨立倫理委員會INDInv estigati onal New Drug新藥臨床研究IRBIn stituti onal Review Board機構審查委員會ITTInten ti on-to-treat意向性分析（統計學）IVDIn Vitro Diag no stic體外診斷IVRSIn teractive Voice Resp onse System互動語音應答系統IWRSin teractive web resp onse system交互式網絡響應系統MAMarketing Approval/Authorization上市許可證MCAMedici nes Con trol Ag

7、ency英國藥品監(jiān)督局MHWMi nistry of Health and Welfare日本衛(wèi)生福利部MIDASMigrai ne Disability Assessme nt偏頭痛殘疾程度評估問卷MSQMigrai ne-Specific Quality of Life questi onna偏頭痛特異性生活質量問卷NDANew Drug Applicati on新藥申請NECNew Drug En tity新化學實體NIHNatio nal In stitutes of Health國家衛(wèi)生研究所（美國）PIPrin cipal Inv estigator主要研究者PLProduct L

8、ice nse產品許可證PMAPre-market Approval (Applicati on)上市前許可（申請）PPPer Protocol符合方案集PSIStatisticians in the Pharmaceutical Industry制藥業(yè)統計學家協會QAQuality Assura nee質量保證QCQuality Con trol質量控制RARegulatory Authorities監(jiān)督管理部門SASite Assessme nt現場評估SAESerious Adverse Eve nt嚴重不良事件SAPStatistical An alysis Pla n統計分析計劃SA

9、RSerious Adverse Reacti on嚴重不良反應SDSource Data/Docume nt原始數據/文件SDSubject Diary受試者日記SFDAState Food and Drug Administration國家食品藥品監(jiān)督管理局縮略語英文全稱中文全稱SDVSource Data Verificati on原始數據核準SELSubject En rollme nt Log受試者入選表SISub-i nv estigator助理研究者SISponsor-lnv estigator申辦研究者SICSubject Identification Code受試者識別代碼S

10、IGNScottish Intercollegiate Guidelines Network蘇格蘭會際指南網絡標準SOPStan dard Operat ing Procedure標準操作規(guī)程SPLStudy Personnel List研究人員名單SSSafety An alysis Set安全分析集SSLSubject Scree ning Log受試者篩選表T&RTest and Refere nee Product受試和參比試劑UAEUn expected Adverse Event預料外不良事件ULNUpper Limit Normal正常值上限WHOWorld Health Org

11、a ni zatio n世界衛(wèi)生組織WHO-ICDRAWHO Intern ati onal Con fere nee of Drug Regulatory AuthoritiesWHO國際藥品管理當局會議無縮略語AApproval批準Audit or in specti on稽查/視察Audit report稽查報告Auditor稽查員Bias偏性/偏倚Bioequivale nee生物等效應Bla nk con trol空白對照Bli nd codes編制盲底Bli nd review盲態(tài)審核Bli nd review盲態(tài)檢杳Bli nding method盲法Bli ndin g/mas

12、k ing盲法/設盲CCase history病歷Cli nical equivale nee臨床等效應Cli ni cal study臨床研究Cli nical trial臨床試驗Co-i nv estigator合作研究者Comparis on對照Complia nee依從性縮略語英文全稱中文全稱Composite variable復合變量Con siste ncy test致性檢驗Con tract/ agreeme nt協議/合同Con trol group對照組Coord in ati ng committee協調委員會DData man ageme nt數據管理Docume nta

13、ti on記錄/文件Drop out脫落EEffective ness:療效End point終點八、En dpo int Criteria終點指標En dpo int criteria/ measureme nt終點指標Equivale nee:等效性Esse ntial Docume ntati on:必需文件Ethics committee倫理委員會Excelle nt顯效Exclusion criteria排除標準FFailure無效/失敗Final point終點八、IInclusion Criteria入選表準Inclusion criteria入選標準Information Ga

14、thering信息收集In itial meet ing啟動會議In specti on檢察/視察In stituti on in specti on機構檢杳In terim an alysis期中分析Inv estigati onal Product試驗藥物Inv estigator研究者LLost of follow up失訪MMo nitor監(jiān)察員Mon itori ng監(jiān)杳Monitoring Plan監(jiān)察計劃Mon itori ng Report監(jiān)察報告Multi-ce nter Trial多中心試驗NNo n-cli nical Study非臨床研究Non-i nferiority

15、非劣效性縮略語英文全稱中文全稱OObedie nee依從性Open-label非盲Original medical record原始醫(yī)療記錄Outcome結果Outcome Assessme nt結果評價Outcome assessme nt結果指標評價Outcome measureme nt結果指標PPatient file病人檔案Patie nt history病歷Placebo:安慰劑Placebo con trol安慰劑對照Precli nical study臨床前研究Primary en dpo int主要終點Primary variable:主要變量Protocol試驗方案Prot

16、ocol Ame ndme nts修正案QQuery list query form應用疑問表RRan domizati on隨機Refere nee Product參比制劑SSafety evaluati on安全性評價Safety set安全性評價的數據集Sample size樣本量樣本大小Scale of ordered categorical rat ings有序分類指標Secon dary variable次要變量Sequenee試驗次序Simple Ran domizati on簡單隨機Si ngle bli nding單盲Site audit:試驗機構稽查Stan dard op

17、erat ing procedure標準操作規(guī)程Sponsor申辦者Sponsor-inv estigator申辦研究者Study Audit研究稽查Study audit研究稽查Study Site研究中心Subgroup亞組Sub-i nv estigator助理研究者縮略語英文全稱中文全稱Subject受試者Subject受試者Subject diary受試者日記Subject En rollme nt受試者入選Subject en rollme nt log受試者入選表Subject Identification Code List受試者識別代碼表Subject Recruitme n

18、t:受試者招募Subject scree ning log受試者篩選表System audit:系統稽查System Audit系統稽查TTest Product受試制劑Treatme nt group試驗組Trial error試驗誤差Trial In itial Meet ing試驗啟動會議Trial Master File試驗總檔案Trial objective:試驗目的Trial site試驗場所Triple bli ndi ng二盲Two on e-side test雙單側檢驗UUn-bli nding揭盲2、血尿檢查英文縮略語縮略語英文全稱中文全稱血常規(guī)ALallergy lymp

19、hocyte變異淋巴細胞BASObasophilic granul ocyte嗜堿性粒細胞EOSeosimophil嗜酸性粒細胞GRgranul ocyte粒性白細胞HCThematocrit紅細胞比積HGBhemoglob in血紅蛋白LYMlymphocyte淋巴細胞MCHmean corpusular hemoglob in平均紅細胞血紅蛋白含量MCHCmea n corpusular hemoglob in concern tration平均紅細胞血紅蛋白濃度MCVmean corpusular volume平均紅細胞體積MIDmid-value中值細胞MONOmono cytes單核

20、細胞總數縮略語英文全稱中文全稱MPVmean platelet volume平均血小板體積NEUn eutrophilic granul ocyte中性粒細胞PCTplateletocrit血小板比積PDWplatelet distribution width血小板分布寬度PLT/BPCplatelet coun t/blood platelet count血小板計數RBCred blood cell紅細胞計數RDWred blood cell volume distribution width紅細胞分布寬度WBCwhite blood cell白細胞血生化a -HBDa -hydroxybu

21、tyric dehydrogenasea -羥丁酸脫氫酶a-AGa-acid glycoprote ina酸性糖蛋白ALBalbumin白蛋白ALP/AKPalkali ne phosphatase堿性磷酸酶ALTala nine amiotra nsferase丙氨酸氨基轉移酶谷丙轉氨酶AMYserum amylase淀粉酶ASOan tistreptolysi n抗鏈球菌溶血素OASTaspartate aminotran sferase門冬氨酸氨基轉移酶谷草轉氨酶BUNusea n itroge n尿素氮C3compleme nt C3補體C3C4compleme nt C4補體C4Ca

22、serum calcium鈣CHEcholi nesterase膽堿酯酶CHOLcholesterol膽固醇CKcreati ne kin ase肌酸激酶CK-MBcreat ine kin ase-MB肌酸激酶同工酶CRE、Crcreati nine肌酐CRPC- reactive prote inC反應性蛋白cTNTtrop onin T肌鈣蛋白TDB/DBILdirect bilirub in直接膽紅素y -GT丫 -glutamyl transpeptadase谷氨酰轉肽酶/轉肽酶GLOB/GLOglobulin球蛋白GLUglucose血糖GSPglycated serum prot

23、糖化血清蛋白HDL-Chigh-de nsity lipoprotein cholesterol高密度脂蛋白IBILin direct bilirub in游離膽紅素LDHlactate dehydroge nase乳酸脫氫酶LDL-Clow-de nsity lipoprotein cholesterol低密度脂蛋白IgAimmuno glob in A免疫球蛋白AJoGimmuno glob in G免疫球蛋白G縮略語英文全稱中文全稱igMimmuno glob in M免疫球蛋白Mipinorganic phosphate無機磷Lp(a)lipoprotein (a)脂蛋白（a）Mgse

24、rum magn esium鎂MTPmili-total protein微量蛋白MYOGmyoglob in肌紅蛋白RFrheumatoid factor類風濕因子TB/TBILtotal bilirub in總膽紅素TBAtotal biliary acid總膽汁酸TGtriglyceride甘油三脂TPtotal protein總蛋白UA/URICuric acid尿酸UREAurea尿素VLDLvery low-de nsity lipoprote in極低密度脂蛋白尿常規(guī)Addis countaddis count艾迪氏計數BILbilirubi n尿膽紅素BLDblood隱血/潛血B

25、UN尿素氮GLUglucose尿葡萄糖HPhigh power objective每高倍視野KETket one尿酮體LEUleucocyte尿白細胞LPlow power objective每低倍視野NITn itrite亞硝酸鹽PHacidity尿酸堿度PROprotein尿蛋白OBoccult blood test大便隱血試驗SGspecific gravity尿比重URO/UBGurobili nogen尿膽原WBCwhite blood cell白細胞電解質NaSodium鈉Kkalium鉀Clchloride氯Gacalcium鈣Mgmagn esium鎂體液常規(guī)縮略語英文全稱中文

26、全稱CSFcerebrosp inal腦積夜Pandypan dy龐氏試驗乙肝標志物HBVhepatitis B virus乙肝病毒HBsAghepatitis B surface an tige n乙肝表面抗原HBsAban tibody to hepatitis surface an tige n乙肝表面抗體HBcAghepatitis B core an tige n乙肝核心抗原HBcAban tibody to hepatitis B core an tige n乙肝核心抗體HBeAghepatitis B e-a ntige n乙肝e抗原HBeAban tibody to hepat

27、itis B e-a ntige n乙肝e抗體ELISAen zymeli nked immuno sorbe ntassy酶聯免疫吸附試驗HAVhepatitis A virus甲肝病毒HCVhepatitis C virus丙肝病毒輸血免疫全套HBVhepatitis B virus乙型肝炎病毒HCVhepatitis C virus丙型肝炎病毒TPtrep on ema pallidum梅毒螺旋體HIVhuma n immuno deficie ncy virus人類免疫缺陷病毒3、實驗室英文縮略語英文全稱縮略語中文全稱Accuracy準確度Alb白蛋白Alpha spe nding f

28、un cti on消耗函數An alysis sets統計分析的數據集Atte nu ated Total Reflecti onATR衰減全反射法AUCss穩(wěn)態(tài)血藥濃度時間曲線下面積:Block層Block size每段的長度Carryover effect延滯效應Categorical variable分類變量Cav平均濃度circular dichroismCD圓二色譜cleara neeCL清除率Cmax峰濃度英文全稱縮略語中文全稱Con fide nee in terval可信區(qū)間Con fide nee level置信水平Crossover desig n交叉設計Cross-ove

29、r Study交叉研究Css穩(wěn)濃度Cure痊愈Database建立數據庫Descriptive statistical an alysis描述性統計分析DF波動系統Dichotomies二分類Diviatio n偏差Dose-reacti on relati on劑量-反應關系Double dummy雙模擬Double dummy tech nique雙盲雙模擬技術Differe ntial Scanning CalorimeterDSC差示掃描熱量計Emerge ncy env elope應急信件Factorial desig n析因設計Fixed-dose procedure固定劑量法Fo

30、rced titrati on強制滴定Full an alysis set全分析集GC FTIR氣相色譜-傅利葉紅外聯用GC MS氣相色譜-質譜聯用Gen eric drug通用名藥Global assessme nt variable全局評價變量Group seque ntial desig n成組序貫設計Health econo mic evaluatio nHEV健康經濟學評價Hypothesis test假設檢驗Hypothesis test ing假設檢驗Improveme nt好轉Last observati on carry forwardLOCF最接近次觀察的結轉LC MS液相色譜-質譜聯用Last observati on carry forwardLOCF最近次觀察的結轉Logic check邏輯檢查Limit of Quan tizati onLOQ定量限Marketing approval/ authorization上市許可證英文全稱縮略語中文全稱Mass spectrumMS質譜Matched pair匹配配對Ma