藥物臨床試驗英文縮寫120

1、文檔編碼 : CQ5B8L6W4W10 HH4V6I4Z6X5 ZA4P8N1Z8Y1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. 7103、試驗室英文縮寫. 更新日期： 2022 年 1 月 20 日1 1、藥物臨床試驗英文縮略語縮略語英文全稱中文全稱AC Active control 陽性對比 /活性對比ADE Adverse Drug Event 藥物不良大事藥物不良反應ADR Adverse Drug Reaction 不良大事AE Adverse Event 助理爭論者AI Assistant Investigator 近似致死劑量ALD Approximate

2、Lethal Dose 曲線下面積AUC Area under the cure 體質指數(shù)BMI Body Mass Index 運算機幫忙試驗設計CATD Computer-assisted trial design 合作爭論者CI Co-investigator 和諧爭論者COI Coordinating Investigator 臨床爭論和諧者CRC Clinical Research Coordinator 病例報告表 /病例記錄表CRF Case report form/ case record form CRO Contract Research Organization 合同爭論

3、組織臨床爭論申請CSA Clinical Study Application 臨床試驗申請CTA Clinical Trial Application 臨床試驗免責CTX Clinical Trial Exemption 臨床試驗方案CTP Clinical Trial Protocol 臨床試驗報告CTR Clinical Trial Report 功能殘疾量表DAS Disability assessment schedule 數(shù)據(jù)安全及監(jiān)控委員會DSMB Data Safety and monitoring Board 心電圖ECG Electrocardiogram 電子數(shù)據(jù)采集系統(tǒng)E

4、DC Electronic Data Capture 電子數(shù)據(jù)處理系統(tǒng)EDP Electronic Data Processing 肌電圖儀EMG Electromyography 全分析集FAS Full analysis set 美國食品與藥品治理局FDA Food and Drug Administration 總結報告FR Final Report 總體評估量表GAS Global Assessment Scale 藥物臨床試驗質量治理規(guī)范GCP Good Clinical Practice 藥物非臨床試驗質量治理規(guī)范GLP Good Laboratory Practice 藥品生產質

5、量治理規(guī)范GMP Good Manufacturing Practice 頭痛影響測定問卷HIT-6 Headache Impact Test 爭論者手冊IB Investigator s Brochure2 縮略語 英文全稱 中文全稱IBR Institution review board 機構審查委員會IC Informed Consent 知情同意ICF Informed Consent Form 知情同意書ICH International Conference on Harmonization 國際和諧會議IDM Independent Data Monitoring 獨立數(shù)據(jù)監(jiān)察I

6、DMC Independent Data Monitoring Committee 獨立數(shù)據(jù)監(jiān)察委員會IEC Independent Ethics Committee 獨立倫理委員會IND Investigational New Drug 新藥臨床爭論IRB Institutional Review Board 機構審查委員會ITT Intention-to-treat 意向性分析 統(tǒng)計學）IVD In Vitro Diagnostic 體外診斷IVRS Interactive Voice Response System 互動語音應答系統(tǒng)IWRS interactive web respons

7、e system 交互式網(wǎng)絡響應系統(tǒng)MA Marketing Approval/Authorization 上市許可證MCA Medicines Control Agency 英國藥品監(jiān)督局MHW Ministry of Health and Welfare 日本衛(wèi)生福利部MIDAS Migraine Disability Assessment 偏頭痛殘疾程度評估問卷MSQ Migraine-Specific Quality of Life questionnaire 偏頭痛特異性生活質量問卷NDA New Drug Application 新藥申請NEC New Drug Entity 新化

8、學實體NIH National Institutes of Health 國家衛(wèi)生爭論所（美國）PI Principal Investigator 主要爭論者PL Product License 產品許可證PMA Pre-market Approval Application 上市前許可（申請）PP Per Protocol 符合方案集PSI Statisticians in the Pharmaceutical Industry 制藥業(yè)統(tǒng)計學家協(xié)會QA Quality Assurance 質量保證QC Quality Control 質量把握RA Regulatory Authorities

9、 監(jiān)督治理部門SA Site Assessment 現(xiàn)場評估SAE Serious Adverse Event 嚴肅不良大事SAP Statistical Analysis Plan 統(tǒng)計分析方案SAR Serious Adverse Reaction 嚴肅不良反應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)督治理局3 縮略語 英文全稱 中文全稱SDV Source Data Verification 原始數(shù)據(jù)核準SEL Subject

10、Enrollment Log 受試者入選表SI Sub-investigator 助理爭論者SI Sponsor-Investigator 申辦爭論者SIC Subject Identification Code 受試者識別代碼SIGN Scottish Intercollegiate Guidelines Network 蘇格蘭會際指南網(wǎng)絡標準SOP Standard Operating Procedure 標準操作規(guī)程SPL Study Personnel List 爭論人員名單SS Safety Analysis Set 安全分析集SSL Subject Screening Log 受試

11、者選擇表T&R Test and Reference Product 受試和參比試劑UAE Unexpected Adverse Event 預料外不良大事ULN Upper Limit Normal 正常值上限WHO World Health Organization 世界衛(wèi)生組織WHO-ICDRA WHO International Conference of Drug Regulatory Authorities WHO 國際藥品治理當局會議無縮略語A Approval 批準稽查視察Audit or inspection 稽查報告Audit report B 稽查員Auditor Bia

12、s 偏性/偏倚Bioequivalence 生物等效應Blank control 空白對比Blind codes 編制盲底盲態(tài)審核Blind review C 盲態(tài)檢查Blind review Blinding method 盲法Blinding/masking 盲法/設盲Case history 病歷Clinical equivalence 臨床等效應Clinical study 臨床爭論Clinical trial 臨床試驗合作爭論者Co-investigator 對比Comparison 依從性Compliance 4 縮略語英文全稱中文全稱D Composite variable 復合

13、變量Consistency test 一樣性檢驗Contract/ agreement 協(xié)議合同Control group 對比組Coordinating committee 和諧委員會Data management 數(shù)據(jù)治理Documentation 記錄/文件Drop out 脫落Effectiveness 療效End point 終點E Endpoint Criteria 終點指標Endpoint criteria/ measurement 終點指標Equivalence 等效性F Essential Documentation 必需文件Ethics committee 倫理委員會Exc

14、ellent 顯效Exclusion criteria 排除標準Failure 無效/失敗Final point 終點I 入選表準Inclusion Criteria Inclusion criteria 入選標準Information Gathering 信息收集Initial meeting 啟動會議Inspection 檢察/視察Institution inspection 機構檢查Interim analysis 期中分析L Investigational Product 試驗藥物Investigator 爭論者Lost of follow up 失訪監(jiān)察員Monitor M 監(jiān)查Mo

15、nitoring Monitoring Plan 監(jiān)察方案N Monitoring Report 監(jiān)察報告Multi-center Trial 多中心試驗Non-clinical Study 非臨床爭論非劣效性Non-inferiority 5 縮略語英文全稱中文全稱O Obedience 依從性Open-label 非盲Original medical record 原始醫(yī)療記錄Outcome 結果P Outcome Assessment 結果評判Outcome assessment 結果指標評判Outcome measurement 結果指標Patient file 病人檔案Patient

16、 history 病歷Placebo 勸慰劑Placebo control 勸慰劑對比Preclinical study 臨床前爭論主要終點Primary endpoint Q 主要變量Primary variable Protocol 試驗方案Protocol Amendments 修正案Query list query form 應用疑問表R Randomization 隨機參比制劑Reference Product 安全性評判Safety evaluation 安全性評判的數(shù)據(jù)集Safety set 樣本量樣本大小Sample size Scale of ordered categori

17、cal ratings 有序分類指標S Secondary variable 次要變量試驗次序Sequence 簡潔隨機Simple Randomization 單盲Single blinding 試驗機構稽查Site audit Standard operating procedure 標準操作規(guī)程Sponsor 申辦者Sponsor-investigator 申辦爭論者Study Audit 爭論稽查Study audit 爭論稽查Study Site 爭論中心Subgroup 亞組Sub-investigator 助理爭論者6 縮略語英文全稱中文全稱Subject 受試者受試者Subje

18、ct 受試者日記Subject diary 受試者入選Subject Enrollment Subject enrollment log Subject Identification Code List 受試者入選表 受試者識別代碼表T Subject Recruitment 受試者招募受試者選擇表Subject screening log 系統(tǒng)稽查System audit 系統(tǒng)稽查System Audit 受試制劑Test Product 試驗組Treatment group 試驗誤差Trial error 試驗啟動會議Trial Initial Meeting 試驗總檔案Trial Mas

19、ter File Trial objective 試驗目的Trial site 試驗場所U Triple blinding 三盲Two one-side test 雙單側檢驗Un-blinding 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)AL allergy lymphocyte 變異淋巴細胞BASO basophilic granulocyte 嗜堿性粒細胞EOS eosimophil 嗜酸性粒細胞GR granulocyte 粒性白細胞HCT hematocrit 紅細胞比積HGB hemoglobin 血紅蛋白LYM lymphocyte 淋巴細胞MCH mean corp

20、usular 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MCV mean corpusular volume 平均紅細胞體積MID mid-value 中值細胞MONO monocytes 單核細胞總數(shù)7 縮略語英文全稱中文全稱MPV mean platelet volume 平均血小板體積NEU neutrophilic granulocyte 中性粒細胞PCT plateletocrit 血小板比積PDW platelet distribution width 血小板分布寬

21、度PLT/BPC platelet count/blood platelet count 血小板計數(shù)RBC red blood cell 紅細胞計數(shù)RDW red blood cell volume distribution width 紅細胞分布寬度WBC white blood cell 白細胞血生化 -HBD -hydroxybutyric dehydrogenase 羥丁酸脫氫酶a酸性糖蛋白a-AG a-acid glycoprotein ALB albumin 白蛋白ALP/AKP alkaline phosphatase 堿性磷酸酶ALT alanine amiotransfera

22、se 丙氨酸氨基轉移酶/谷丙轉氨酶AMY serum amylase 淀粉酶ASO antistreptolysin 抗鏈球菌溶血素 O AST aspartate aminotransferase 門冬氨酸氨基轉移酶/谷草轉氨酶BUN usea nitrogen 尿素氮C3 complement C3 補體 C3 C4 complement C4 補體 C4 Ca serum calcium 鈣CHE cholinesterase 膽堿酯酶CHOL cholesterol 膽固醇CK creatine kinase 肌酸激酶肌酸激酶同工酶CK-MB creatine kinase-MB CR

23、E、Cr creatinine 肌酐C 反應性蛋白CRP C- reactive protein cTNT troponin T 肌鈣蛋白 T DB/DBIL direct bilirubin 直接膽紅素 -GT -glutamyl transpeptadase 谷氨酰轉肽酶 /轉肽酶GLOB/GLO globulin 球蛋白GLU glucose 血糖GSP glycated serum prot 糖化血清蛋白HDL-C high-density lipoprotein cholesterol 高密度脂蛋白IBIL indirect bilirubin 游離膽紅素LDH lactate de

24、hydrogenase 乳酸脫氫酶LDL-C low-density lipoprotein cholesterol 低密度脂蛋白IgA immunoglobin A 免疫球蛋白 A IgG immunoglobin G 免疫球蛋白 G 8 縮略語英文全稱中文全稱IgM immunoglobin M 免疫球蛋白 M IP inorganic phosphate 無機磷Lpa lipoprotein（a）脂蛋白（ a）Mg serum magnesium 鎂MTP mili-total protein 微量蛋白MYOG myoglobin 肌紅蛋白RF rheumatoid factor 類風濕

25、因子TB/TBIL total bilirubin 總膽紅素TBA total biliary acid 總膽汁酸TG triglyceride 甘油三脂TP total protein 總蛋白UA/URIC uric acid 尿酸UREA urea 尿素VLDL very low-density lipoprotein 極低密度脂蛋白尿常規(guī)Addis count addis count 艾迪氏計數(shù)BIL bilirubin 尿膽紅素BLD blood 隱血/潛血BUN glucose 尿素氮GLU 尿葡萄糖HP high power objective 每高倍視野KET ketone 尿酮

26、體LEU leucocyte 尿白細胞LP low power objective 每低倍視野亞硝酸鹽NIT nitrite PH acidity 尿酸堿度尿蛋白PRO protein OB occult blood test 大便隱血試驗SG specific gravity 尿比重URO/UBG urobilinogen 尿膽原WBC white blood cell 白細胞電解質Na Sodium 鈉K kalium 鉀Cl chloride 氯Ga calcium 鈣Mg magnesium 鎂體液常規(guī)9 縮略語cerebrospinal 英文全稱中文全稱CSF 腦積夜Pandy pa

27、ndy 龐氏試驗乙肝標志物HBV hepatitis B virus 乙肝病毒HBsAg hepatitis B surface antigen 乙肝表面抗原HBsAb antibody to hepatitis surface antigen 乙肝表面抗體HBcAg hepatitis B core antigen 乙肝核心抗原HBcAb antibody to hepatitis B core antigen 乙肝核心抗體HBeAg hepatitis B e-antigen 乙肝 e 抗原HBeAb antibody to hepatitis B e-antigen 乙肝 e 抗體ELI

28、SA enzymelinked immunosorbentassy 酶聯(lián)免疫吸附試驗HAV hepatitis A virus 甲肝病毒HCV hepatitis C virus 丙肝病毒輸血免疫全套HBV hepatitis B virus 乙型肝炎病毒HCV hepatitis C virus 丙型肝炎病毒TP treponema pallidum 梅毒螺旋體HIV human immunodeficiency virus 人類免疫缺陷病毒3、試驗室英文縮略語英文全稱縮略語精確度中文全稱Accuracy 白蛋白Alb 消耗函數(shù)Alpha spending function Analysis

29、 sets 統(tǒng)計分析的數(shù)據(jù)集Attenuated Total Reflection ATR 衰減全反射法穩(wěn)態(tài)血藥濃度時間曲線下面積AUCss Block 層Block size 每段的長度Carryover effect CD 延滯效應Categorical variable 分類變量Cav 平均濃度circular dichroism 圓二色譜清除率clearance CL 峰濃度Cmax 10 英文全稱縮略語可信區(qū)間中文全稱Confidence interval 置信水平Confidence level 交叉設計Crossover design 交叉爭論Cross-over Study 穩(wěn)

30、濃度Css 痊愈Cure 建立數(shù)據(jù)庫Database Descriptive statistical analysis 描述性統(tǒng)計分析DF 波動系統(tǒng)Dichotomies 二分類Diviation 偏差Dose-reaction relation 劑量反應關系Double dummy 雙模擬Double dummy technique 雙盲雙模擬技術Differential Scanning Calorimeter DSC 差示掃描熱量計應急信件Emergency envelope 析因設計Factorial design 固定劑量法Fixed-dose procedure 強制滴定Force

31、d titration 全分析集Full analysis set GCFTIR 氣相色譜傅利葉紅外聯(lián)用GCMS HEV 氣相色譜質譜聯(lián)用通用名藥Generic drug 全局評判變量Global assessment variable 成組序貫設計Group sequential design 健康經(jīng)濟學評判Health economic evaluation 假設檢驗Hypothesis test Hypothesis testing 假設檢驗LOCF Improvement 好轉Last observation carry forward 最接近一次觀看的結轉液相色譜質譜聯(lián)用LCMS LOCF Last observation carry forward 最近一次觀看的結轉規(guī)律檢查Logic check LOQ Limit of Quantization 定量限上市許可證Marketing approval/ authorization 11 英文全稱 縮略語 中文全稱Mass spectrum MS 質譜Matched pair 匹配配對Maximu