藥物臨床試驗英文縮寫

1、藥物臨床試驗英文縮寫縮略語英文全稱中文全稱ADEAdverse Drug Event藥物不良事件ADRAdverse Drug React ion藥物不良反應AEAdverse Event不良事件AIAssista nt In vestigator助理研究者BMIBody Mass In dex體質(zhì)指數(shù)CICo-i nvestigator合作研究者COICoordin at ing In vestigator協(xié)調(diào)研究者CRCCli ni cal Research Coordin ator臨床研究協(xié)調(diào)者CRFCase Report Form病歷報告表CROCon tract Research O

2、rga ni zatio n合同研究組織CSACli ni cal Study Applicati on臨床研究申請CTAClinical Trial Application臨床試驗申請CTXCli nical Trial Exempti on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DSMBData Safety and mon itori ng Board數(shù)據(jù)安全及監(jiān)控委員會EDCElectronic Data Capture電子數(shù)據(jù)采集系統(tǒng)EDPElectr onic Data Proces

3、s ing電子數(shù)據(jù)處理系統(tǒng)FDAFood and Drug Adm ini strati on美國食品與藥品管理局FRFinal Report總結報告GCPGood Cli nical Practice藥物臨床試驗質(zhì)量管理規(guī)GCPGood Laboratory Practice藥物非臨床試驗質(zhì)量管理規(guī)GMPGood Manu facturi ng Practice藥品生產(chǎn)質(zhì)量官理規(guī)IBInvestigator s Brochure研究者手冊ICIn formed Consent知情同意ICFIn formed Consent Form知情冋意書ICHIntern ati onalConfere

4、nceonHarmoni zati on國際協(xié)調(diào)會議IDMIn depe ndent Data Mon itori ng獨立數(shù)據(jù)監(jiān)察IDMCIn depe ndent Data Mon itori ng Committee獨立數(shù)據(jù)監(jiān)察委員會IECIn depe ndent Ethics Committee獨立倫理委員會INDIn vestigati onal New Drug新藥臨床研究IRBInstitutional Review Board機構審查委員會IVDIn Vitro Diag no stic體外診斷IVRSIn teractive Voice Resp onse System互動

5、語音應答系統(tǒng)MAMarketing Approval/Authorization上市許可證MCAMedici nes Con trol Age ncy英國藥品監(jiān)督局MHWMin istry of Health and Welfare日本衛(wèi)生福利部NDANew Drug Applicati on新藥申請NECNew Drug En tity新化學實體縮略語英文全稱中文全稱NIHNational Institutes of Health國家衛(wèi)生研究所（美國）PIPrin cipal In vestigator主要研究者PLProduct Lice nse產(chǎn)品許可證PMAPre-market App

6、roval (Applicati on)上市前許可（申請）PSIStatisticia ns inthe PharmaceuticalIn dustry制藥業(yè)統(tǒng)計學家協(xié)會QAQuality Assura nee質(zhì)量保證QCQuality Con trol質(zhì)里控制RARegulatory Authorities監(jiān)督管理部門SASite Assessme nt現(xiàn)場評估SAESerious Adverse Event嚴重不良事件SAPStatistical An alysis Pla n統(tǒng)計分析計劃SARSerious Adverse React ion嚴重不良反應SDSource Data/Doc

7、ume nt原始數(shù)據(jù)/文件SDSubject Diary受試者日記SFDAState Food and Drug Admi nistrati on國家食品藥品監(jiān)督管理局SDVSource Data Verificati on原始數(shù)據(jù)核準SELSubject En rollme nt Log受試者入選表SISub-i nvestigator助理研究者SISponsor-In vestigator申辦研究者SICSubject Identification Code受試者識別代碼SOPStan dard Operati ng Procedure標準操作規(guī)程SPLStudy Personnel Li

8、st研究人員SSLSubject Scree ning Log受試者帥選表T&RTest and Refere nee Product受試和參比試劑UAEUn expected Adverse Event預料外不良事件WHOWorld Health Orga ni zati on世界衛(wèi)生組織WHO-ICDRAWHO Intern ati onal Conference ofDrug Regulatory AuthoritiesWHO!際藥品管理當局會議藥物臨床試驗英文縮寫英文全稱中文全稱Accuracy準確度Active con trol, AC陽性對照活性對照Adverse drug rea

9、ctio n, ADR藥物不良反應Adverse eve nt, AE不良事件Adverse medical events不良醫(yī)學事件Adverse react ion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 spe nding function消耗函數(shù)ALT丙氨酸氨基轉(zhuǎn)換酶An alysis sets統(tǒng)計分析的數(shù)據(jù)集Approval批準Assista nt in vestigator助理研究者AST天門冬酸氨基轉(zhuǎn)換酶ATR衰減全反射法AUCss穩(wěn)態(tài)血藥濃度時間曲線下面積Audit稽查Audit or in sp

10、ect ion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Blank 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/mask ing盲法/設盲Block層Block size每段的長度Carryover effect延滯效應Case history病歷Case report form/ case record form CRF病例報告表病例記錄表英文全稱中文全稱Categorical v

11、ariable分類變量Cav平均濃度CD圓二色譜CL清除率Cli ni cal equivale nee臨床等效應Cli ni eal study臨床研究Cli ni eal 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Cli nical trial exemption CTX臨床試驗免責Clinical trial protocol CTP臨床試驗方案Cli ni cal trial/ study report臨床試驗報告Cmax峰濃度Co-i nvestigator合作研究者Compa

12、ris on對照Complia nee依從性Composite variable復合變量Computer-assisted trial desig n CATD計算機輔助試驗設計Con fide nee in terval可信區(qū)間Con fide nee level置信水平Con siste ncy test一致性檢驗Con tract research orga ni zati on CRO合同研究組織Con tract/ agreeme nt協(xié)議/合同Con trol group對照組Coordin at ing committee協(xié)調(diào)委員會Crea肌酐CRF(case report fo

13、rm)病例報告表Crossover desig n交叉設計Cross-over Study交叉研究Css穩(wěn)濃度Cure痊愈Data man ageme nt數(shù)據(jù)管理Database建立數(shù)據(jù)庫Descriptive statistical an alysis描述性統(tǒng)計分析DF波動系統(tǒng)Dichotomies二分類Diviatio n偏差英文全稱中文全稱Docume ntati on記錄/文件Dose-react ion relati on劑量-反應關系Double dummy雙模擬Double dummy tech nique雙盲雙模擬技術Drop out脫落DSC差示掃描熱量計Effective

14、 ness療效Electro nic data capture EDC電子數(shù)據(jù)采集系統(tǒng)Electr onic data process ing EDP電子數(shù)據(jù)處理系統(tǒng)Emerge ncy en velope應急信件End point終占八、En dpo int Criteria終點指標Endpoint criteria/ measurement終點指標Equivale nee等效性Esse ntial Docume ntatio n必需文件Ethics committee倫理委員會Excelle nt顯效Exclusion criteria排除標準Factorial desig n析因設計Fa

15、ilure無效失敗Final point終占八、Fixed-dose procedure固定劑量法Forced 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(lián)用GC- MS氣相色譜-質(zhì)譜聯(lián)用Gen eric drug通用名藥Global assessme nt variable全局評價變量GLU血糖Good cli ni cal practice, GCP藥物臨床試驗質(zhì)量管理規(guī)Good manufacture practice, GMP藥品生產(chǎn)質(zhì)量官理規(guī)Good non-cli ni cal laboratory practice

16、, GLP藥物非臨床研究質(zhì)量官理規(guī)Group seque ntial desig n成組序貫設計Health econo mic evaluati on, HEV健康經(jīng)濟學評價Hypothesis test假設檢驗Hypothesis test ing假設檢驗英文全稱中文全稱Improveme nt好轉(zhuǎn)In clusi on Criteria入選表準Inclusion criteria入選標準In depe ndent ethics committee IEC獨立倫理委員會Information consent form ICF知情冋意書Information Gathering信息收集In

17、formed consent IC知情同意In itial meet ing啟動會議In spect ion檢察/視察In stituti on in specti on機構檢查In stituti on review board, IBR機構審查委員會Inten tio n-to treat ITT意向性分析（統(tǒng)計學）In teractive voice resp onse system IVRS互動式語音應答系統(tǒng)In terim an alysis期中分析Intern ati onalConferenceofHarmoni zati on ICH人用藥品注冊技術要求國際技術協(xié)調(diào)會國際協(xié)調(diào)會

18、議In vestigati onal Product試驗藥物In vestigator研究者Investigator s brochure, IB研究者手冊Last observati on carry forward, LOCF最接近一次觀祭的結轉(zhuǎn)LC MS液相色譜-質(zhì)譜聯(lián)用LD50板數(shù)致死劑量LOCF, Last observati on carry forward最近一次觀祭的結轉(zhuǎn)Logic check邏輯檢杳LOQ (Limit of Qua ntizati on)定量限Lost of follow up失訪Marketing approval/ authorization上市許可證M

19、atched pair匹配配對Miss ing value缺失值Mixed effect model混合效應模式Mo nitor監(jiān)察員Mon itori ng監(jiān)杳Monitoring Plan監(jiān)察計劃Monitoring Report監(jiān)察報告MRT平均滯留時間MS質(zhì)譜MS- MS質(zhì)譜-質(zhì)譜聯(lián)用英文全稱中文全稱MTD( Maximum Tolerated Dose )最大耐受劑量Multi-ce nter Trial多中心試驗New chemical en tity 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

20、研究Non-i nferiority非劣效性Non-parametric statistics非參數(shù)統(tǒng)計方法Obedie nee依從性ODR旋光光譜Open-label非盲Optio nal titratio n隨意滴定Origi nal 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Outlier離群值Parallel group desig n平行組設計Parameter estimati on參數(shù)估計Parametric statis

21、tics參數(shù)統(tǒng)計方法Patient file病人檔案Patie nt history病歷Per protocol PP符合方案集Placebo安慰劑Placebo con trol安慰劑對照Polytomies多分類Power檢驗效能Precisi on精密度Precli nical study臨床前研究Primary en dpo int主要終點Primary variable主要變量Prin ciple in vestigator PI主要研究者Product lice nse PL產(chǎn)品許可證Protocol試驗方案Protocol Ame ndme nts修正案Quality assur

22、a nee QA質(zhì)量保證英文全稱中文全稱Quality assura nee un it QAU質(zhì)量保證部門Quality control QC質(zhì)量控制Query list query form應用疑問表Ran domizati on隨機Range check圍檢查Rati ng scale量表Refere nee Product參比制劑Regulatory authorities RA監(jiān)督管理部門Replicati on可重復RSD日和日間相對標準差Run in準備期Safety evaluati on安全性評價Safety set安全性評價的數(shù)據(jù)集Sample size樣本量樣本大小Sca

23、le of ordered categorical rat ings有序分類指標Secon dary variable次要變量Sequenee試驗次序Serious adverse event SAE嚴重不良事件Serious adverse reacti on SAR嚴重不良反應Serious ness嚴重性Severity嚴重程度Severity嚴重程度Signi fica nt level檢驗水準Simple Ran domizatio n簡單隨機Si ngle bli nding單盲Site audit試驗機構稽查SOP試驗室的標準操作規(guī)程Source data SD原始數(shù)據(jù)Sourc

24、e data verificatio n SDV原始數(shù)據(jù)核準Source docume nt SD原始文件Specificity特異性Sponsor申辦者Sponsor-in vestigator申辦研究者Stan dard curve標準曲線Stan dard operati ng procedure SOP標準操作規(guī)程Statistic統(tǒng)計量Statistical an alysis pla n統(tǒng)計分析計劃英文全稱中文全稱Statistical model統(tǒng)計模型Statistical tables統(tǒng)計分析表Stratified分層Study Audit研究稽查Study audit研究稽

25、查Study Site研究中心Subgroup亞組Sub-i nvestigator助理研究者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 ide ntificati on code SIC受試者識別代碼Subject Ide ntificati on Code List受試者識別代碼表Subject Recruitme nt受試者招募Subject scree ning log受試者師選表Superiority檢驗Survival an

26、alysis生存分析SXRD單晶X-射線衍射System audit系統(tǒng)稽查System Audit系統(tǒng)稽查T1/2消除半衰期Target variable目標變量T- BIL總膽紅素T- CHO總膽固醇Test Product受試制劑TG熱重分析TLC HPLC制備色譜Tmax峰時間TP總蛋白Tran sformatio n變量變換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試驗目的英文全稱中文全稱Trial site試驗場所Triple

27、 bli nding二盲Two on e-side test雙單側(cè)檢驗Un-bli nding揭盲Un expected adverse eve nt UAE預料外不良事件UV VIS紫外-可見吸收光譜Variability變異Variable變量Visual an alogy scale直觀類比打分法Visual check人工檢查Vuln erable subject弱勢受試者Wash-out洗脫Washout period洗脫期實驗室檢查英文縮寫英文全稱中文全稱血常規(guī)WBC white blood cell cou nt白細胞計數(shù)GR% granu locyte中性粒細胞百分比LY% l

28、ymphocyte淋巴細胞百分比MID%中值細胞百分比EOS% eosimophil嗜酸性粒細胞百分比AL% allergy lymphocyte變異淋巴細胞百分比ST%中性桿狀粒細胞百分比RBC red blood cell紅細胞計數(shù)HGB hemoglobi n血紅蛋白HCT hematocrit 紅細胞比積紅細胞比積MCV mean corpusular volume平均紅細胞體積MCH mea n corpusular hemoglob in平均紅細胞血紅蛋白含量MCHC mea ncorpusularhemoglob inconcern trati on平均紅細胞血紅蛋白濃度RDW

29、red blood cell volume distributi on width紅細胞分布寬度變異PLT/BPC plateletcount/blood plateletcou nt血小板計數(shù)MPV mea n platelet volume平均血小板體積PCT plateletocrit血小板比積PDW platelet distribution width血小板分布寬度尿便常規(guī)PH acidity酸堿度NIT nitrite亞硝酸鹽GLU glucose尿糖SG specific gravity比重PRO protein尿蛋白BLD blood隱血BIL bilirubi n尿膽紅素UR

30、O urobil inogen尿膽原WBC white blood cell白細胞addish 計數(shù) addish count艾迪氏計數(shù)/HP high power objective每高倍視野/LP low power objective每低倍視野英文全稱中文全稱OB occult blood test大便隱血試驗體液常規(guī)CSF cerebrosp inal腦積夜Pandy pandy龐氏試驗生化檢驗TB total bilirubin總膽紅素DB direct bilirub in直接膽紅素TP total protein總蛋白ALB albumin白蛋白GLOB globulin球蛋白U

31、REA urea尿素CREA creati nine肌肝UA uric acid尿酸GLU glucose血糖ALT ala nine amiotra nsferase丙氨酸氨基轉(zhuǎn)移酶AST aspartate aminotran sferase門冬氨酸氨基轉(zhuǎn)移酶GGT Y -glutamyl transpeptadase谷氨酰轉(zhuǎn)肽酶CK creat ine kin ase肌酸肌酶CK-MB creati ne kin ase-MB肌酸肌酶同工酶LDH lactate dehydroge nase乳酸脫氫酶a -HBD a -hydroxybutyric dehydrogenasea 羥丁酸脫氫酶AMY serum amylase血淀粉酶TG triglyceride肝油三脂CHOL cholesterol膽固醇HDL-chigh-de nsitylipoproteincholesterol高密度脂蛋白LDL-clow-de nsitylipoproteincholester