藥物臨床試驗(yàn)英文詞匯及縮寫.doc

藥物臨床試驗(yàn)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 藥物不良反應(yīng)AE Adverse Event 不良事件AI Assistant Investigator 助理研究者BMI Body Mass Index 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(bào)告表CRO Contract 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(yàn)申請CTX Clinical Trial Exemption 臨床試驗(yàn)免責(zé)CTP Clinical Trial Protocol 臨床試驗(yàn)方案CTR Clinical Trial Report 臨床試驗(yàn)報(bào)告DSMB Data Safety and monitoring Board 數(shù)據(jù)安全及監(jiān)控委員會(huì)EDC Electronic Data Capture 電子數(shù)據(jù)采集系統(tǒng)EDP Electronic 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(bào)告GCP Good Clinical Practice 藥物臨床試驗(yàn)質(zhì)量管理規(guī)范GCP Good Laboratory Practice 藥物非臨床試驗(yàn)質(zhì)量管理規(guī)范GMP Good Manufacturing Practice 藥品生產(chǎn)質(zhì)量管理規(guī)范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 International Conference on Harmonization 國際協(xié)調(diào)會(huì)議IDM Independent Data Monitoring 獨(dú)立數(shù)據(jù)監(jiān)察IDMC Independent Data Monitoring Committee 獨(dú)立數(shù)據(jù)監(jiān)察委員會(huì)IEC Independent Ethics Committee 獨(dú)立倫理委員會(huì)IND Investigational New Drug 新藥臨床研究IRB Institutional Review Board 機(jī)構(gòu)審查委員會(huì)IVD In Vitro Diagnostic 體外診斷IVRS Interactive Voice Response System 互動(dòng)語音應(yīng)答系統(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NDA New Drug Application 新藥申請NEC New Drug Entity 新化學(xué)實(shí)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-market Approval (Application) 上市前許可（申請）PSI Statisticians in the Pharmaceutical Industry 制藥業(yè)統(tǒng)計(jì)學(xué)家協(xié)會(huì)QA Quality Assurance 質(zhì)量保證QC Quality Control 質(zhì)量控制RA Regulatory Authorities 監(jiān)督管理部門SA Site Assessment 現(xiàn)場評估SAE Serious Adverse Event 嚴(yán)重不良事件SAP Statistical Analysis Plan 統(tǒng)計(jì)分析計(jì)劃SAR Serious Adverse Reaction 嚴(yán)重不良反應(yīng)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)督管理局SDV Source Data Verification 原始數(shù)據(jù)核準(zhǔn)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(biāo)準(zhǔn)操作規(guī)程SPL Study Personnel List 研究人員名單SSL Subject Screening Log 受試者篩選表T&R Test and Reference Product 受試和參比試劑UAE Unexpected Adverse Event 預(yù)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(dāng)局會(huì)議 藥物臨床試驗(yàn)英文縮寫英文全稱 中文全稱Accuracy準(zhǔn)確度Active control, AC陽性對照 活性對照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(yīng)Case history病歷Case 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/ study report 臨床試驗(yàn)報(bào)告Cmax峰濃度Co-investigator 合作研究者Comparison對照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對照組Coordinating committee 協(xié)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 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(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終點(diǎn)指標(biāo)Endpoint criteria/ measurement 終點(diǎn)指標(biāo)Equivalence 等效性Essential Documentation必需文件Ethics committee 倫理委員會(huì)Excellent顯效Exclusion criteria排除標(biāo)準(zhǔn)Factorial design析因設(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)評價(jià)Hypothesis test假設(shè)檢驗(yàn)Hypothesis testing假設(shè)檢驗(yàn)Improvement好轉(zhuǎn)Inclusion Criteria入選表準(zhǔn)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Information Gathering信息收集Informed consent IC知情同意Initial meeting啟動(dòng)會(huì)議Inspection檢察/視察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 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(huì) 國際協(xié)調(diào)會(huì)議Investigational Product試驗(yàn)藥物Investigator研究者Investigators brochure, IB研究者手冊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Mixed effect model混合效應(yīng)模式Monitor監(jiān)察員Monitoring監(jiān)查Monitoring Plan監(jiān)察計(jì)劃Monitoring Report監(jiān)察報(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-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)果評價(jià)Outcome assessment結(jié)果指標(biāo)評價(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安慰劑對照Polytomies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Principle investigator PI主要研究者Product license PL產(chǎn)品許可證Protocol試驗(yàn)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(yīng)用疑問表Randomization隨機(jī)Range check范圍檢查Rating scale量表Reference Product參比制劑Regulatory authorities RA監(jiān)督管理部門Replication可重復(fù)RSD日內(nèi)和日間相對標(biāo)準(zhǔn)差Run in準(zhǔn)備期Safety evaluation安全性評價(jià)Safety set安全性評價(jià)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(biāo)Secondary variable次要變量Sequence 試驗(yàn)次序Serious 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Severity 嚴(yán)重程度Significant level檢驗(yàn)水準(zhǔn)Simple Randomization簡單隨機(jī)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 SD原始數(shù)據(jù)Source data verification SDV原始數(shù)據(jù)核準(zhǔn)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(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 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 Identification 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(yàn)Survival analysis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(biāo)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 Initial Meeting 試驗(yàn)啟動(dòng)會(huì)議Trial Master File試驗(yàn)總檔案Trial objective試驗(yàn)?zāi)康腡rial site 試驗(yàn)場所Triple blinding三盲Two one-side test 雙單側(cè)檢驗(yàn)Un-blinding 揭盲Unexpected adverse event UAE預(yù)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 period洗脫期 實(shí)驗(yàn)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(xì)胞計(jì)數(shù) GR% granulocyte中性粒細(xì)胞百分比 LY% lymphocyte 淋巴細(xì)胞百分比 MID% 中值細(xì)胞百分比 EOS% eosimophil 嗜酸性粒細(xì)胞百分比 AL% allergy lymphocyte 變異淋巴細(xì)胞百分比 ST% 中性桿狀粒細(xì)胞百分比 RBC red blood cell 紅細(xì)胞計(jì)數(shù) HGB hemoglobin 血紅蛋白 HCT hematocrit 紅細(xì)胞比積 紅細(xì)胞比積MCV mean corpusular volume平均紅細(xì)胞體積 MCH mean corpusular hemoglobin平均紅細(xì)胞血紅蛋白含量 MCHC mean corpusular hemoglobin concerntration 平均紅細(xì)胞血紅蛋白濃度 RDW red blood cell volume distribution width 紅細(xì)胞分布寬度變異 PLT/BPC platelet count/blood platelet count血小板計(jì)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 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(xì)胞 addish計(jì)數(shù) addish count 艾迪氏計(jì)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(yàn) 體液常規(guī) CSF cerebrospinal 腦積夜 Pandy pandy 龐氏試驗(yàn) 生化檢驗(yàn) 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 transpeptadase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 -hydroxybutyric 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 lipo