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ADE Adverse Drug Event 藥物不良事件ADR Adverse Drug Reaction 藥物不良反響AE Adverse Event 不良事件AI Assistant Investigator 助理研究者BMI Body Mass Inde* 體質(zhì)指數(shù)CI Co-investigator 合作研究者COI Coordinating Investigator 協(xié)調(diào)研究者CRC Clinical Research Coordinator 臨床研究協(xié)調(diào)者 CRF Case Report Form 病歷報告表CRO Contract

2、 Research Organization 合同研究組織CSA Clinical Study Application 臨床研究申請CTA Clinical Trial Application 臨床試驗申請CT* Clinical Trial E*emption 臨床試驗免責CTP Clinical Trial Protocol 臨床試驗方案CTR Clinical Trial Report 臨床試驗報告DSMB Data Safety and monitoring Board 數(shù)據(jù)平安及監(jiān)控委員會EDC Electronic Data Capture 電子數(shù)據(jù)采集系統(tǒng)EDP Electron

3、ic Data Processing 電子數(shù)據(jù)處理系統(tǒng)FDA Food and Drug Administration 美國食品與藥品管理局FR Final Report 總結(jié)報告GCP Good Clinical Practice 藥物臨床試驗質(zhì)量管理規(guī)GLP Good Laboratory Practice 藥物非臨床試驗質(zhì)量管理規(guī)GMP Good Manufacturing Practice 藥品生產(chǎn)質(zhì)量管理規(guī)IB Investigators Brochure 研究者手冊IC Informed Consent 知情同意ICF Informed Consent Form 知情同意書ICH

4、International Conference on Harmonization 國際協(xié)調(diào)會議IDM Independent Data Monitoring 獨立數(shù)據(jù)監(jiān)察IDMC Independent Data Monitoring mittee 獨立數(shù)據(jù)監(jiān)察委員會IEC Independent Ethics mittee 獨立倫理委員會IND Investigational New Drug 新藥臨床研究IRB Institutional Review Board 機構(gòu)審查委員會IVD In Vitro Diagnostic 體外診斷IVRS Interactive Voice Resp

5、onse System 互動語音應答系統(tǒng)MA Marketing Approval/Authorization 上市許可證MCA Medicines Control Agency 英國藥品監(jiān)視局MHW Ministry of Health and Welfare 日本衛(wèi)生福利部NDA New Drug Application 新藥申請NEC New Drug Entity 新化學實體NIH National Institutes of Health 國家衛(wèi)生研究所美國PI Principal Investigator 主要研究者PL Product License 產(chǎn)品許可證PMA Pre-m

6、arket Approval (Application) 上市前許可申請PSI Statisticians in the Pharmaceutical Industry 制藥業(yè)統(tǒng)計學家協(xié)會QA Quality Assurance 質(zhì)量保證QC Quality Control 質(zhì)量控制RA Regulatory Authorities 監(jiān)視管理部門SA Site Assessment 現(xiàn)場評估SAE Serious Adverse Event 嚴重不良事件SAP Statistical Analysis Plan 統(tǒng)計分析方案SAR Serious Adverse Reaction 嚴重不良反響

7、SD Source Data/Document 原始數(shù)據(jù)/文件SD Subject Diary 受試者日記SFDA State Food and Drug Administration 國家食品藥品監(jiān)視管理局SDV Source Data Verification 原始數(shù)據(jù)核準SEL Subject Enrollment Log 受試者入選表SI Sub-investigator 助理研究者SI Sponsor-Investigator 申辦研究者SIC Subject Identification Code 受試者識別代碼SOP Standard Operating Procedure 標準

8、操作規(guī)程SPL Study Personnel List 研究人員SSL Subject Screening Log 受試者篩選表T&R Test and Reference Product 受試和參比試劑UAE Une*pected Adverse Event 預料外不良事件WHO World Health Organization 世界衛(wèi)生組織WHO-ICDRAWHO International Conference of Drug Regulatory AuthoritiesWHO國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 co

9、ntrol, AC陽性對照 活性對照Adverse drug reaction, ADR藥物不良反響Adverse event, AE不良事件Adverse medical events不良醫(yī)學事件Adverse reaction藥物不良反響Alb白蛋白ALDAppro*imate 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)計分析的數(shù)據(jù)集Approval批準Assistant investigator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

10、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(shè)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Categ

11、orical variable分類變量Cav平均濃度CD 圓二色譜CL去除率Clinical equivalence臨床等效應Clinical study臨床研究Clinical study report臨床試驗的總結(jié)報告Clinical trial臨床試驗Clinical trial application CTA 臨床試驗申請Clinical trial e*emption CT*臨床試驗免責Clinical trial protocol CTP臨床試驗方案Clinical trial/ study report 臨床試驗報告Cma*峰濃度Co-investigator 合作研究者pari

12、son對照pliance依從性posite variable復合變量puter-assisted trial design CATD計算機輔助試驗設(shè)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 mittee 協(xié)調(diào)委員會Crea肌酐CRF(case report form)病例報告表Crossover design穿插設(shè)計Cros

13、s-over Study穿插研究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 劑量反響關(guān)系Double dummy雙模擬Double dummy technique雙盲雙模擬技術(shù)Drop out 脫落DSC 差示掃描熱量計Effectiveness療效Electronic data capture EDC電子數(shù)據(jù)采集系統(tǒng)Elect

14、ronic data processing EDP 電子數(shù)據(jù)處理系統(tǒng)Emergency envelope應急信件End point終點Endpoint Criteria終點指標Endpoint criteria/ measurement 終點指標Equivalence 等效性Essential Documentation必需文件Ethics mittee 倫理委員會E*cellent顯效E*clusion criteria排除標準Factorial design析因設(shè)計Failure無效 失敗Final point終點Fi*ed-dose procedure固定劑量法Forced titrat

15、ion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(zhì)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(zhì)量管理規(guī)Good manufacture practice, GMP 藥品生產(chǎn)質(zhì)量管理規(guī)Good non-clinical laboratory practice, GLP 藥物非臨床研究質(zhì)量管理規(guī)Group sequential design成組序貫設(shè)計Health economic evaluatio

16、n, HEV*經(jīng)濟學評價Hypothesis test假設(shè)檢驗Hypothesis testing假設(shè)檢驗Improvement好轉(zhuǎn)Inclusion Criteria入選表準Inclusion criteria 入選標準Independent ethics mittee IEC 獨立倫理委員會Information consent form ICF知情同意書Information Gathering信息收集Informed consent IC知情同意Initial meeting啟動會議Inspection檢察/視察Institution inspection 機構(gòu)檢查Institutio

17、n review board, IBR 機構(gòu)審查委員會Intention-to treat 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International Conference of Harmonization ICH人用藥品注冊技術(shù)要求國際技術(shù)協(xié)調(diào)會 國際協(xié)調(diào)會議Investigational Product試驗藥物Investigator研究者Investigators brochure, IB研究者手冊Last observation carry forward,

18、 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LOCF, Last observation carry forward最近一次觀察的結(jié)轉(zhuǎn)Logic check邏輯檢查LOQ (Limit of Quantization)定量限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Mi*ed effect model混合效應模式Monitor監(jiān)察員Monitoring監(jiān)查Monitoring Plan監(jiān)察方案Monitoring Report

19、監(jiān)察報告MRT平均滯留時間MS質(zhì)譜MSMS質(zhì)譜質(zhì)譜聯(lián)用MTDMa*imum Tolerated Dose 最大耐受劑量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O(shè)DR 旋光光譜Open-label非盲Optional titration隨意滴定Original medical record

20、原始醫(yī)療記錄Oute 結(jié)果Oute Assessment結(jié)果評價Oute assessment結(jié)果指標評價Oute measurement 結(jié)果指標Outlier離群值Parallel group design平行組設(shè)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撫慰劑Placebo control撫慰劑對照Polytomies多分類Power檢驗效能Precision精細度Preclinical study臨床前

21、研究Primary endpoint主要終點Primary variable主要變量Principle investigator PI主要研究者Product license PL產(chǎn)品許可證Protocol試驗方案Protocol Amendments修正案Quality assurance QA質(zhì)量保證Quality assurance unit 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Randomization隨機Range check圍檢查Rating scale量表Reference Product參比制劑R

22、egulatory authorities RA監(jiān)視管理部門Replication可重復RSD日和日間相對標準差Run in準備期Safety evaluation平安性評價Safety set平安性評價的數(shù)據(jù)集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Serious adverse event SAE 嚴重不良事件Serious adverse reaction SAR 嚴重不良反響Seriousness嚴重性Severity嚴重程度Seve

23、rity 嚴重程度Significant level檢驗水準Simple Randomization簡單隨機Single blinding 單盲Site audit 試驗機構(gòu)稽查SOP 試驗室的標準操作規(guī)程Source data SD原始數(shù)據(jù)Source data verification SDV原始數(shù)據(jù)核準Source document SD 原始文件Specificity 特異性Sponsor申辦者Sponsor-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Sta

24、tistical analysis plan統(tǒng)計分析方案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 研究稽查Study Site研究中心Subgroup 亞組Sub-investigator 助理研究者Subject受試者Subject受試者Subject 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 I

25、dentification Code List受試者識別代碼表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S*RD單晶*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TBIL總膽紅素TCHO總膽固醇Test Product受試制劑TG 熱重分析TLC、HPLC制備色譜Tma* 峰時間TP總蛋白Transformation 變量變換Treatment group試驗組Trial erro

26、r 試驗誤差Trial Initial Meeting 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 blinding三盲Two one-side test 雙單側(cè)檢驗Un-blinding 揭盲Une*pected adverse event UAE預料外不良事件UVVIS紫外可見吸收光譜Variability變異Variable變量Visual analogy scale直觀類比打分法Visual check人工檢查Vulnerable subject弱勢受試者Wash-out洗脫Washout p

27、eriod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 count白細胞計數(shù) GR% granulocyte中性粒細胞百分比 LY% lymphocyte 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 hemoglobin 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 M

28、CH mean corpusular hemoglobin平均紅細胞血紅蛋白含量 MCHC mean corpusular hemoglobin concerntration 平均紅細胞血紅蛋白濃度 RDW red blood cell volume distribution width 紅細胞分布寬度變異 PLT/BPC platelet count/blood platelet count血小板計數(shù) MPV mean 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

29、 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 bilirubin 尿膽紅素 URO urobilinogen 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 OB occult blood test 大便隱血試驗 體液常規(guī) CSF cereb

30、rospinal 腦積夜 Pandy pandy 龐氏試驗 生化檢驗 TB total bilirubin 總膽紅素 DB direct bilirubin 直接膽紅素 TP total protein 總蛋白 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 丙氨酸氨基轉(zhuǎn)移酶 AST aspartate aminotransferase 門冬氨酸氨基轉(zhuǎn)移酶 GGT -glutamyl trans

31、peptadase谷氨酰轉(zhuǎn)肽酶 CK creatine kinase 肌酸肌酶 CK-MB creatine kinase-MB 肌酸肌酶同工酶 LDH lactate dehydrogenase 乳酸脫氫酶 -HBD -hydro*ybutyric dehydrogenase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-c high-density lipoprotein cholesterol 高密度脂蛋白 LDL-c low-density lipoprotein cholesterol 低密度脂蛋白 VLDL very low-density lipop