藥物臨床試驗(yàn)英文詞匯資料及其縮寫(xiě)

1、-藥物臨床試驗(yàn)英文縮寫(xiě)縮略語(yǔ)英文全稱(chēng)中文全稱(chēng)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

2、合同研究組織CSAClinical Study Application臨床研究申請(qǐng)CTAClinical Trial Application臨床試驗(yàn)申請(qǐng)CTXClinical Trial Exemption臨床試驗(yàn)免責(zé)CTPClinical Trial Protocol臨床試驗(yàn)方案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)FDAFood and

3、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(shū)ICHInternational Conference on Harmonization國(guó)際協(xié)調(diào)會(huì)議IDMIn

4、dependent Data Monitoring獨(dú)立數(shù)據(jù)監(jiān)察IDMCIndependent Data Monitoring Committee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IVRSInteractive V oice Response System互動(dòng)語(yǔ)音應(yīng)答系統(tǒng)MAMarketing Approval/Authorization上市許可證M

5、CAMedicines Control Agency英國(guó)藥品監(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)）PIPrincipal Investigator主要研究者PLProduct License產(chǎn)品許可證PMAPre-market Approval (Application)上市前許可（申請(qǐng)）-縮略語(yǔ)英文全稱(chēng)中文全稱(chēng)PSIStatisticians in the Ph

6、armaceutical 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(mén)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SFDAState Food and Drug Admi

7、nistration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 Reference Produc

8、t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 ofWHO 國(guó)際藥品管理當(dāng)局會(huì)議Drug Regulatory Authorities藥物臨床試驗(yàn)英文縮寫(xiě)英文全稱(chēng)中文全稱(chēng)AccuracyActive control, ACAdverse drug reaction, ADRAdverse event, AEAdverse medical eventsAdverse reactionAlbALD （ Approxima

9、te Lethal DoseALPAlpha spending function）準(zhǔn)確度陽(yáng)性對(duì)照活性對(duì)照藥物不良反應(yīng)不良事件不良醫(yī)學(xué)事件藥物不良反應(yīng)白蛋白近似致死劑量堿性磷酸酶消耗函數(shù)-英文全稱(chēng)中文全稱(chēng)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(mén)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 c

10、ontrol空白對(duì)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(zhǎng)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(lèi)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 r

11、eport臨床試驗(yàn)的總結(jié)報(bào)告Clinical trial臨床試驗(yàn)Clinical trial applicationCTA臨床試驗(yàn)申請(qǐng)Clinical trial exemptionCTX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(duì)照Compliance依從性-英文全稱(chēng)Composite variableComputer-assisted trial design CATDConfidence intervalConf

12、idence levelConsistency testContract research organization CROContract/ agreementControl groupCoordinating committeeCreaCRF(case report form)Crossover designCross-over StudyCssCureData managementDatabaseDescriptive statistical analysisDFDichotomiesDiviationDocumentationDose-reaction relationDouble d

13、ummyDouble dummy techniqueDrop outDSCEffectivenessElectronic data capture EDCElectronic data processing EDPEmergency envelopeEnd pointEndpoint CriteriaEndpoint criteria/ measurementEquivalenceEssential DocumentationEthics committeeExcellentExclusion criteriaFactorial design中文全稱(chēng)復(fù)合變量計(jì)算機(jī)輔助試驗(yàn)設(shè)計(jì)可信區(qū)間置信水平一

14、致性檢驗(yàn)合同研究組織協(xié)議合同對(duì)照組協(xié)調(diào)委員會(huì)肌酐病例報(bào)告表交叉設(shè)計(jì)交叉研究穩(wěn)濃度痊愈數(shù)據(jù)管理建立數(shù)據(jù)庫(kù)描述性統(tǒng)計(jì)分析波動(dòng)系統(tǒng)二分類(lèi)偏差記錄文件劑量反應(yīng)關(guān)系雙模擬雙盲雙模擬技術(shù)脫落差示掃描熱量計(jì)療效電子數(shù)據(jù)采集系統(tǒng)電子數(shù)據(jù)處理系統(tǒng)應(yīng)急信件終點(diǎn)終點(diǎn)指標(biāo)終點(diǎn)指標(biāo)等效性必需文件倫理委員會(huì)顯效排除標(biāo)準(zhǔn)析因設(shè)計(jì)-英文全稱(chēng)中文全稱(chēng)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Generic drug通用名藥Glo

15、bal 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-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(píng)價(jià)Hypothesis test假設(shè)檢驗(yàn)Hypothesis testing假設(shè)檢驗(yàn)Improvement好轉(zhuǎn)Inclusion C

16、riteria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 formICF知情同意書(shū)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-totreat ITT意向性分析 ( 統(tǒng)計(jì)學(xué)）Interactive voice

17、response system IVRS互動(dòng)式語(yǔ)音應(yīng)答系統(tǒng)Interim analysis期中分析InternationalConferenceof Harmonization人用藥品注冊(cè)技術(shù)要求國(guó)際技術(shù)協(xié)調(diào)會(huì)國(guó)ICH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, LOCF最接近一次觀察的結(jié)轉(zhuǎn)LC MS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

18、結(jié)轉(zhuǎn)-英文全稱(chēng)中文全稱(chēng)Logic check邏輯檢查L(zhǎng)OQ (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MSMS質(zhì)譜質(zhì)譜聯(lián)用MTD （Maximum Tolerated Dose ）最大耐受劑量Multi-cente

19、r Trial多中心試驗(yàn)New chemical entityNCE新化學(xué)實(shí)體New drug applicationNDA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 Assessment結(jié)果評(píng)價(jià)Outcome assessment結(jié)果指標(biāo)評(píng)價(jià)Outcome measure

20、ment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(duì)照-英文全稱(chēng)中文全稱(chēng)Polytomies多分類(lèi)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 investi

21、gatorPI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(mén)Quality control QC質(zhì)量控制Query listquery form應(yīng)用疑問(wèn)表Randomization隨機(jī)Range check范圍檢查Rating scale量表Reference Product參比制劑Regulatory authoritiesRA監(jiān)督管理部門(mén)Replication可重復(fù)RSD日內(nèi)和日間相對(duì)標(biāo)準(zhǔn)差Run in

22、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 categorical ratings有序分類(lèi)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(jiǎn)單隨機(jī)Single blindin

23、g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)-英文全稱(chēng)Source document SDSpecificitySponsorSponsor-investigatorStandard curveStandard operating procedureSOPStatisticStatistical analysis planStatistical modelStatistical tablesStratifiedStudy AuditStudy auditStudy Sit

24、eSubgroupSub-investigatorSubjectSubjectSubject diarySubject EnrollmentSubject enrollment logSubject identification codeSICSubject Identification Code ListSubject RecruitmentSubject screening logSuperioritySurvival analysisSXRDSystem auditSystem AuditT1/2Target variableT BILT CHOTest ProductTGTLC 、 H

25、PLCTmaxTPTransformation中文全稱(chēng)原始文件特異性申辦者申辦研究者標(biāo)準(zhǔn)曲線標(biāo)準(zhǔn)操作規(guī)程統(tǒng)計(jì)量統(tǒng)計(jì)分析計(jì)劃統(tǒng)計(jì)模型統(tǒng)計(jì)分析表分層研究稽查研究稽查研究中心亞組助理研究者受試者受試者受試者日記受試者入選受試者入選表受試者識(shí)別代碼受試者識(shí)別代碼表受試者招募受試者篩選表檢驗(yàn)生存分析單晶 X 射線衍射系統(tǒng)稽查系統(tǒng)稽查消除半衰期目標(biāo)變量總膽紅素總膽固醇受試制劑熱重分析制備色譜峰時(shí)間總蛋白變量變換-英文全稱(chēng)Treatment groupTrial errorTrial Initial MeetingTrial Master FileTrial objectiveTrial siteTripl

26、e blindingTwo one-side testUn-blindingUnexpected adverse eventUV VISVariabilityVariableVisual analogy scaleVisual checkVulnerable subjectWash-outWashout periodUAE中文全稱(chēng)試驗(yàn)組試驗(yàn)誤差試驗(yàn)啟動(dòng)會(huì)議試驗(yàn)總檔案試驗(yàn)?zāi)康脑囼?yàn)場(chǎng)所三盲雙單側(cè)檢驗(yàn)揭盲預(yù)料外不良事件紫外可見(jiàn)吸收光譜變異變量直觀類(lèi)比打分法人工檢查弱勢(shì)受試者洗脫洗脫期實(shí)驗(yàn)室檢查英文縮寫(xiě)英文全稱(chēng)中文全稱(chēng)血常規(guī)WBC white blood cell count白細(xì)胞計(jì)數(shù)GR% gran

27、ulocyte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MCHCmeancorpusularhemoglobin平均紅細(xì)胞血紅蛋白濃度concern

28、trationRDW red blood cell volume distribution width紅細(xì)胞分布寬度變異-英文全稱(chēng)PLT/BPC platelet count/blood platelet countMPV mean platelet volumePCT plateletocritPDW platelet distribution width中文全稱(chēng)血小板計(jì)數(shù)平均血小板體積血小板比積血小板分布寬度尿便常規(guī)PH acidityNIT nitriteGLU glucoseSG specific gravityPRO proteinBLD bloodBIL bilirubinURO

29、urobilinogenWBC white blood celladdish 計(jì)數(shù) addish count/HP high power objective/LP low power objectiveOB occult blood test酸堿度亞硝酸鹽尿糖比重尿蛋白隱血尿膽紅素尿膽原白細(xì)胞艾迪氏計(jì)數(shù)每高倍視野每低倍視野大便隱血試驗(yàn)體液常規(guī)CSF cerebrospinalPandy pandy腦積夜龐氏試驗(yàn)生化檢驗(yàn)TB total bilirubinDB direct bilirubinTP total proteinALB albuminGLOB globulinUREA ureaCRE

30、A creatinineUA uric acidGLU glucoseALT alanine amiotransferaseAST aspartate aminotransferaseGGT -glutamyl transpeptadaseCK creatine kinaseCK-MB creatine kinase-MBLDH lactate dehydrogenase-HBD -hydroxybutyric dehydrogenaseAMY serum amylaseCHOL cholesterol總膽紅素直接膽紅素總蛋白白蛋白球蛋白尿素肌肝尿酸血糖丙氨酸氨基轉(zhuǎn)移酶門(mén)冬氨酸氨基轉(zhuǎn)移酶谷氨酰

31、轉(zhuǎn)肽酶肌酸肌酶肌酸肌酶同工酶乳酸脫氫酶羥丁酸脫氫酶血淀粉酶肝油三脂膽固醇-英文全稱(chēng)中文全稱(chēng)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 lipoprotein極低密度脂蛋白Ca serum calcium鈣Mg serum magnesium鎂IP inorganic phosphate無(wú)機(jī)磷ALP alkaline phosphatase堿性磷酸酶TBA total biliary acid總膽汁酸ASO

32、antistreptolysin抗鏈球菌溶血素Oa-AG a acid glycoproteina酸性糖蛋白CRP C-reactive protein CRF rheumatoid factorMTP mili-total proteinIgG immunoglobin GIgA immunoglobin AIgM immunoglobin MC3 complement C3C4 complement C4cTNT troponin TMYOG myoglobin反應(yīng)蛋白類(lèi)風(fēng)濕因子微量蛋白免疫球蛋白免疫球蛋白免疫球蛋白補(bǔ)體 C3補(bǔ)體 C4肌鈣蛋白 T肌紅蛋白GAM電解質(zhì)Na sodiumK

33、kaliumCl chlorideGa calciumMg magnesium鈉鉀氯鈣鎂乙肝標(biāo)志物HBV hepatitis B virusHBsAg hepatitis B surface antigenHBsAb antibody to hepatitis surface antigenHBcAg hepatitis B core antigenHBcAb antibody to hepatitis B core antigenHBeAg hepatitis B e-antigenHBeAb antibody to hepatitis B e-antigenELISA enzymelink

34、ed immunosorbentassyHAV hepatitis A virusHCV hepatitis C virus乙肝病毒乙肝表面抗原乙肝表面抗體乙肝核心抗原乙肝核心抗體乙肝 e 抗原乙肝 e 抗體酶聯(lián)免疫吸附試驗(yàn)甲肝病毒丙肝病毒輸血免疫全套HBV hepatitis B virusTP treponema pallidum乙型肝炎病毒丙型肝炎病毒梅毒螺旋體-英文全稱(chēng)中文全稱(chēng)HIV human immunodeficiency virus人類(lèi)免疫缺陷病毒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

35、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(mén)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 repor

36、t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(duì)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分段Block層Block size每段的長(zhǎng)度BUN 尿素氮Carryover effect延滯效應(yīng)Case history病歷-Case report form病例報(bào)告表Case report form/ case record form， CRF 病例報(bào)告表，病例記錄表Categorical

37、variable分類(lèi)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(qǐng)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(duì)照

38、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(duì)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

39、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(kù)Descriptive statistical analysis描述性統(tǒng)計(jì)分析DF波動(dòng)系統(tǒng)Dichotomies二分類(lèi)-Diviation偏差Documentation記錄文件Dose-reaction relation劑量反應(yīng)關(guān)系Double blinding雙盲Double dummy雙模擬Double dummy technique雙盲雙模擬技術(shù)Double-blinding雙盲Drop out脫落DSC 差示掃描熱量計(jì)Effectiveness療效E

40、lectronic 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/ measurement終點(diǎn)指標(biāo)Equivalence等效性Essential documentation必須文件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(wú)效，失敗Final point終點(diǎn)Fixed-dose procedu

41、re固定劑量法Forced titration強(qiáng)制滴定Full analysis 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-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)H

42、ealth economic evaluation，HEV 健康經(jīng)濟(jì)學(xué)評(píng)價(jià)Hypothesis test假設(shè)檢驗(yàn)Hypothesis testing假設(shè)檢驗(yàn)-InternationalConferenceofHarmonization ，ICH 人用藥品注冊(cè)技術(shù)要求國(guó)際技術(shù)協(xié)調(diào)會(huì)，國(guó)際協(xié)調(diào)會(huì)議Improvement好轉(zhuǎn)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(shū)Information gathering信息收集Informed consent，IC知情

43、同意Initial meeting啟動(dòng)會(huì)議Inspection視察檢查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意向治療（臨床領(lǐng)域）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(yǔ)音應(yīng)答系統(tǒng)Interim analysis期中分析Investigator研究者Investigator's brochure，IB研究者手冊(cè)IR紅外吸收光譜Ka吸收速率常Last observation carry forward，LOCF 最接近一次觀察的結(jié)轉(zhuǎn)LC MS 液相色譜質(zhì)譜聯(lián)用LD50板數(shù)