藥物臨床試驗(yàn)英文縮寫

1、藥物臨床試驗(yàn)英文縮寫縮略語(yǔ)英文全稱中文全稱ADEAdverse Drug Event藥物不良事件ADRAdverse Drug Reaction藥物不良反應(yīng)AEAdverse Event不良事件AIAssistant Investigator助理研究者BMIBody Mass Index體質(zhì)指數(shù)CICo-investigator合作研究者COICoordinating Investigator協(xié)調(diào)研究者CRCClinical Research Coordinator臨床研究協(xié)調(diào)者CRFCase Report Form病歷報(bào)告表CROContract Research Organization合

2、同研究組織CSAClinical Study Application臨床研究申請(qǐng)CTAClinical Trial Application臨床試驗(yàn)中請(qǐng)CTXClinical Trial Exemption臨床試驗(yàn)免責(zé)CTPClinical Trial Protocol臨床試驗(yàn)方案縮略語(yǔ)英文全稱中文全稱CTRClinical Trial Report臨床試驗(yàn)報(bào)告DSMBData Safety and monitoring Board數(shù)據(jù)安全及監(jiān)控委員會(huì)EDCElectronic Data Capture電子數(shù)據(jù)采集系統(tǒng)EDPElectronic Data Processing電子數(shù)據(jù)處理系統(tǒng)FD

3、AFood and Drug Administration美國(guó)食品與藥品管理局FRFinal Report總結(jié)報(bào)告GCPGood Clinical Practice藥物臨床試驗(yàn)質(zhì)量管理規(guī)范GCPGood Laboratory Practice藥物非臨床試驗(yàn)質(zhì)量管理規(guī)范GMPGood Manufacturing Practice藥品生產(chǎn)質(zhì)量管理規(guī)范IBInvestigator s Brochure研究者手冊(cè)ICInformed Consent知情同意ICFInformed Consent Form知情同意書ICHInternationalConference onHarmonization國(guó)際協(xié)

4、調(diào)會(huì)議縮略語(yǔ)英文全稱中文全稱IDMIndependent Data Monitoring獨(dú)立數(shù)據(jù)監(jiān)察IDMCIndependent Data MonitoringCommittee獨(dú)立數(shù)據(jù)監(jiān)察委員會(huì)IECIndependent Ethics Committee獨(dú)立倫理委員會(huì)INDInvestigational New Drug新藥臨床研究IRBInstitutional Review Board機(jī)構(gòu)審查委員會(huì)IVDIn Vitro Diagnostic體外診斷IVRSInteractiveVoice ResponseSystem互動(dòng)語(yǔ)音應(yīng)答系統(tǒng)MAMarketingApproval/Autho

5、rization上市許可證MCAMedicines Control Agency英國(guó)約品監(jiān)督局MHWMinistry of Health and Welfare日本衛(wèi)生福利部NDANew Drug Application新藥申請(qǐng)NECNew Drug Entity新化學(xué)實(shí)體NIHNational Institutes of Health國(guó)家衛(wèi)生研究所（美國(guó)）縮略語(yǔ)英文全稱中文全稱PIPrincipal Investigator主要研究者PLProduct License產(chǎn)品許可證PMAPre-marketApproval(Application)上市前許可（申請(qǐng)）PSIStatistician

6、sinthePharmaceutical Industry制藥業(yè)統(tǒng)計(jì)學(xué)家協(xié)會(huì)QAQuality Assurance質(zhì)量保證QCQuality Control質(zhì)量控制RARegulatory Authorities監(jiān)督管理部門SASite Assessment現(xiàn)場(chǎng)評(píng)估SAESerious Adverse Event嚴(yán)重不良事件SAPStatistical Analysis Plan統(tǒng)計(jì)分析計(jì)劃SARSerious Adverse Reaction嚴(yán)重不良反應(yīng)SDSource Data/Document原始數(shù)據(jù)/文件SDSubject Diary受試者日記縮略語(yǔ)英文全稱中文全稱SFDAStateF

7、oodandDrugAdministration國(guó)家食品藥品監(jiān)督管理局SDVSource Data Verification原始數(shù)據(jù)核準(zhǔn)SELSubject Enrollment Log受試者入選表SISub-investigator助理研究者SISponsor-Investigator申辦研究者SICSubject Identification Code受試者識(shí)別代碼SOPStandard Operating Procedure標(biāo)準(zhǔn)操作規(guī)程SPLStudy Personnel List研究人員名單SSLSubject Screening Log受試者篩選表T&RTest and Refere

8、nce Product受試和參比試劑UAEUnexpected Adverse Event預(yù)料外不良事件WHOWorld Health Organization世界衛(wèi)生組織WHO-ICDRAWHO International Conference ofDrug Regulatory AuthoritiesWHOI際約品管理當(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(yáng)性對(duì)照活性對(duì)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)

9、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丙氨酸熟基轉(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天門冬酸敏基轉(zhuǎn)換酶英文全稱中文全稱ATR衰減全反射法AUCss穩(wěn)態(tài)血藥濃度一時(shí)間曲線卜面積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

10、效應(yīng)Blank control空白對(duì)照Blind codes編制盲底Blind review盲態(tài)審核Blind review自態(tài)檢查Blinding method盲法Blinding/masking盲法/設(shè)盲Block層英文全稱中文全稱Block size每段的長(zhǎng)度Carryover effect延滯效應(yīng)Case history病歷Case report form/ case record formCRF病例報(bào)告表病例記錄表Categorical variable分類及量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C

11、linical 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)中請(qǐng)Clinical trial exemption CTX臨床試驗(yàn)免責(zé)英文全稱中文全稱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(duì)照Compliance依從性Composite variable復(fù)合變量Computer-assisted trial design CAT

12、D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(duì)照組Coordinating committee協(xié)調(diào)委員會(huì)英文全稱中文全稱Crea肌酊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

13、建立數(shù)據(jù)庫(kù)Descriptive statistical analysis描述性統(tǒng)計(jì)分析DF波動(dòng)系統(tǒng)Dichotomies二分類Diviation記Documentation記錄/文件Dose-reaction relation劑量-反應(yīng)關(guān)系Double dummy雙模擬英文全稱中文全稱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)

14、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必需義件Ethics committee倫理委員會(huì)Excellent顯效Exclusion criteria排除標(biāo)準(zhǔn)英文全稱中文全稱Factorial design析因設(shè)計(jì)Failure無(wú)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GO FTIR氣相色譜-傅利葉紅外聯(lián)

15、用GC- MS氣相色譜-質(zhì)譜聯(lián)用Generic drug通用名藥Global assessment variable全局評(píng)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-clinicallaboratorypractice, GLP藥物非臨床研究質(zhì)量官理規(guī)范英文全稱中文全稱Group sequential design成組序貫設(shè)計(jì)Health economic evaluation, HEV健康經(jīng)濟(jì)學(xué)評(píng)價(jià)Hypothesis test假設(shè)檢驗(yàn)Hypot

16、hesis 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)英文全稱中文全稱In

17、tention-to treat ITT意向性分析（一統(tǒng)計(jì)學(xué)）Interactive voice response system互動(dòng)式語(yǔ)音應(yīng)答系統(tǒng)IVRSInterim analysis期中分析InternationalConferenceof人用藥品注冊(cè)技術(shù)要求國(guó)際技術(shù)協(xié)調(diào)Harmonization ICH會(huì)國(guó)際協(xié)調(diào)會(huì)議Investigational Product試驗(yàn)藥物Investigator研究者Investigator s brochure, IB研究者手冊(cè)Last observation carry forward,最接次觀察的結(jié)轉(zhuǎn)LOCFLC MS液相色譜-質(zhì)譜聯(lián)用LD50板數(shù)致

18、死劑量LOCF, Last observationcarry最次觀察的結(jié)轉(zhuǎn)forwardLogic check邏輯檢查英文全稱中文全稱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(duì)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MS- MS質(zhì)譜-質(zhì)譜聯(lián)用MT

19、D( Maximum Tolerated Dose )最大耐受劑量Multi-center Trial多中心試驗(yàn)英文全稱中文全稱New chemical entity NCE新化學(xué)實(shí)體New drug application NDA新藥申請(qǐng)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

20、 Assessment結(jié)果評(píng)價(jià)Outcome assessment結(jié)果指標(biāo)評(píng)價(jià)Outcome measurement結(jié)果指標(biāo)英文全稱中文全稱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(duì)照Polytomies多分類Power檢驗(yàn)效能Precision精密度Preclinical study臨床前研究Prim

21、ary endpoint主要終點(diǎn)Primary variable主要變量英文全稱中文全稱Principle investigator PI主要研究者Product license PL產(chǎn)品許可證Protocol試驗(yàn)力泵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

22、Regulatory authorities RA監(jiān)督管理部門Replication可重復(fù)RSD日內(nèi)和日間相對(duì)標(biāo)準(zhǔn)差英文全稱中文全稱Run in準(zhǔn)備期Safety evaluation安全性評(píng)價(jià)Safety set安全性評(píng)價(jià)的數(shù)據(jù)集Sample size樣本量樣本大小Scale of ordered categoricalratings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

23、Severity嚴(yán)重程度Significant level檢驗(yàn)水準(zhǔn)Simple Randomization簡(jiǎn)單隨機(jī)英文全稱中文全稱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)

24、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)分析表英文全稱中文全稱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(shí)別代碼S

25、ubject Identification Code List受試者識(shí)別代碼表Subject Recruitment受試者招募Subject screening log受試者篩選表英文全稱中文全稱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T- BIL總膽紅素T- CHO總膽固醇Test Product受試制劑TG熱重分析TLG HPLC制備色譜Tmax峰時(shí)間TP總蛋白Transformation變量變換英文全稱中文全稱Trea

26、tment 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(chǎng)所Triple blinding二盲Two one-side test雙單側(cè)檢驗(yàn)Un-blinding揭旨Unexpected adverse event UAE預(yù)料外不良事件UW VIS紫外一可見吸收光譜Variability變異Variable變量Visual analogy scale直觀類比打分法Visual check人工檢查英文全稱中義全稱Vulnerable su

27、bject弱勢(shì)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血紅蛋白英文全稱中文全稱HCT hematocrit 紅細(xì)胞比積紅細(xì)胞比積MCV mean corpus

28、ular 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 cellvolumedistribution width紅細(xì)胞分布寬度及異PLT/BPC plateletcount/bloodplatelet 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

29、分布寬度尿便常規(guī)PH acidity酸堿度NIT nitrite亞硝酸鹽GLU glucose尿糖英文全稱中文全稱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Pand

30、y pandy龐氏試驗(yàn)生化檢驗(yàn)TB total bilirubin總膽紅素英文全稱中文全稱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丙氨酸匆基轉(zhuǎn)移酶AST aspartate aminotransferase門冬氨酸熟基轉(zhuǎn)移酶GGT 丫 -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，酶LDH lactate dehydrogenase乳酸脫氫酶a -HBD a -hydroxybutyrica 羥酸脫氫酶英文全稱中文全稱dehydrogenaseAMY serum amylase血淀粉酶TG triglyceride肝油三脂CHOL cholesterol膽固醇HDL-c high-densitylipoproteincholesterol高密度脂蛋白LDL-c low-densitylipoproteinchole