1、ICH臨床部分術語表英文中文activecomparatortreatment陽性對照治療activedose有效劑量activeplacebotreatment陽性安慰劑治療activetreatmentconcurrentcontrol陽性藥物并行對照adaptiveallocation適應性分組法addendum附件add-onstudy在標準治療基礎上的對照試驗adjustdosage調整劑量adjustmentsforcovariates協變量調整administrationinstruction用藥指南administrativecriteria用藥標準adoption采用adve

2、rseconsequence不良后果adversedrugevents(ADE)藥物不良事件adversedrugreaction(ADR)藥物不良反應adverseevent(AE)不良事件adverseexperience不良經驗agonist激動劑alertevent警告事件allocationwithsites臨床試驗點分配法Amendment(totheprotocol)修改（試驗方案）ANCOVA協方差分析antagonist拮抗劑applicablelawsandregulations適用的法律和法規applicableregulatoryrequirement適用的管理條例ap

3、plicationdossier申報資料approval批準approvedformarketing批準上市assaysensitivity檢測方法的靈敏度assessment評估audit稽查auditcertificate稽查證書auditreport稽查報告audittrail稽查過程authorizationrenewal授權更新authorized授權authorizedwithqualification頒發許可證averagedose-responsecurve平均量效曲線backupofthedata數據備份baseline-controlledstudies基線對照研究batc

4、hnumber批號bayesianapproaches貝葉斯方法benefit/riskratio利益/風險比例bias偏差biometrics生物統計birthdefect出生缺陷blindreview盲態檢杳blinding盲法blinding/masking設盲blockdesign區組設計blood-levelpeaks血藥峰值brandname商品名breaktheblind破盲bridgingdatapackage跨越數據集bridgingstudy跨越研究bulksales批量銷售carcinogenicity致癌性carry-overeffect持續效應casereportfo

5、rm(CRF)病例報告表categoricalvariable分類變量causalrelationship因果關系Centralizedallocation集中分配法changefrombaselineresponse基線反應變換法CIOMS國際醫學科學組織理事會clinicaldrugdevelopment臨床藥物開發clinicalresponse臨床反應clinicalsafety臨床安全性clinicalsafetydatamanagement臨床安全性資料管理clinicalsafetyinformation臨床安全性信息clinicaltrial/study臨床試驗/研究combi

6、nationtherapy聯合治療committeeforproprietarymedicalproducts專利醫藥產品委員會companycoredatasheet(CCDS)公司核心資料表companycoresafetyinformation(CCSI)公司核心安全性信息comparabilityoftestgroups試驗組間的可比性comparativeeffectivenessstudies有效性的比較研究comparator對照劑comparator(product)對照（藥物）compassionateuse照顧性應用completeclinicaldatapackage完整

7、的臨床資料集compliance依從性compoundsinsensitivetoethnicfactors對種族因素不敏的藥物concentration-responsevalues濃度一效應值concentration-controlledstudy濃度控制研究concentration-responserelationship濃度一效應關系concomitantmedications伴隨用藥concurrentcontrol并行對照confidentiality保密性confirmatorystudy確認性研究congenitalabnormaly先天性異常consentform知情同意

8、書contentvalidity內容的確實性contract合同contractresearchorganization(CRO)合同研究機構contraindication禁忌證controldrug對照藥controlledtrials對照試驗controlledvocabularies對照詞匯CoordinatingCommittee協調委員會coordinatinginvestigator協調研究者copiesappended副本countryentries參與國家的名單covariateeffect協受歡應coxregressionoutput回歸分析法criteriaforthet

9、erminationofthetrial終止試驗的標準crossovercontrol交叉對照crossoverrdesign交叉設計cross-overstudy交叉研究cross-referencing交叉參閱CTXnumberCIX編號cumulativedose畜積劑量database數據庫dataelement數據要素dataentryandprocessing數據輸入和處理datalockpoint數據鎖定點demographiccharacteristics人口學特征directaccess直接接觸documentation文件dosage劑量dosageform劑型dosage

10、strength規格dosecomparisonconcurrentcontrol劑量比較的并行對照doseinterval劑量間隔doserange劑量范圍doseregimen給藥方案dosetitration劑量滴定dose-responsecurve量效曲線dose-responseinformation量效關系資料dose-responserelationship量效關系dose-responseslope量效斜率dose-responsesurface量效關系面dose-tolerancestudy劑量一耐受性研究dosinginformation劑量信息double-blind雙

11、盲double-blindstudy雙盲試驗double-dummy雙模擬dropout中途退出drugabuse藥物濫用drugdependence藥物依賴drugdevelop藥物開發drugexposurelevel藥物的暴露水平druginteraction藥物相互作用drugmisuse藥物誤用drugregistration藥物注冊drug-concentration藥物濃度durationofdosing用藥時間earlyescape（無效治療后）及早脫離effectiveness有效性electronicdataprocessingsystem(s)電子數據處理系統ENS-CA

12、REsinglecaseformENS-CARE個案表格equivalencetrial等效性試驗estimates預估值ESTRI(ICHelectronicstandardsforthetransferofregulatoryinformation)ICH管理信息傳遞的電子類標準ethicscommittee倫理委員會ethnicfactors種族因素EuroSCaPEformatEuroSCaPE研究格式evaluationofsafety安全性評價eventterms事件術語expedited(alert)report快速報告expirationdate失效期exploratoryst

13、udy探索性研究extendedexposure延長治療external(historical)control回顧性對照extrapolationofforeignclinicaldata國外臨床資料的延用factorialdesigns析因設計factorialtrial析因試驗fatal致命的filetransfer檔案轉換finalreport總結報告fixeddose固定劑量forcedtitration強制性劑量滴定foreignclinicaldata國外臨床資料freetext自由格式文本frequencyofdosing給藥頻率frequentistmethods頻率論方法fu

14、llanalysisset完整的數據分析集fulltext全文本GCP臨床試驗管理規范generalisability,generalisation廣義性genotoxicity遺傳毒性geriatricpopulation老年人群geriatrics老年病學globalassessmentvariable總體評價變量glossaryofspecialterms特殊術語表GoodClinicalPractice(GCP)臨床試驗管理規范groupmean組均值groupsequentialdesigns成組序貫設計half-life半衰期harmonisedregulatorystandard

15、協調管理標準healingrate治愈率historicalcontrol回顧性對照homogeneouspatient群體均一的病人humanpharmacology人體藥理學hysteresis滯后現象ICHprocessICH程序ICHregionsICH區域ICHsteeringcommitteeICH指導委員會identifier鑒定impartialwitness公平的見證人improve改善incapacity機能不全；無能力IND研究性的新藥INDnumberIND編號independentdata-monitoringcommittee(IDMC)獨立的數據監察委員會inde

16、pendentethicscommittee(IEC)獨立的倫理委員會individualcasesafetyreports個例安全性報告individualcharacteristics個體特征individualdifferences個體差異InternationalConferenceonHarmonisation(ICH)國際協調會議informedconsent知情同意informedconsentform知情同意書inspection視察institution(medical)（醫學）研究機構institutionalrenewboard(IRB)機構審評委員會insurances

17、tatement保險說明intensity(severity)嚴重程度；強度intention-to-treatprinciple治療意向原則interaction相互作用interimanalysis中期分析InternationalBirthdate(IBD)國際首次上市日InternationalCommitteeofMedicalJournalEditors醫學雜志國際編輯委員會InternationalDrugMonitoringCentre國際藥物監測中心International-Non-ProprietaryName(INPN)國際非專用名inter-raterreliabil

18、ity評估者間的可靠性intervention干預interventionstudy干預性研究intra-raterreliability評估者內的可靠性intrinsicethnicfactors內在的種族因素in-useeffectiveness使用有效性investigationalproductsaccount-ability研究藥品計數investigationalproductdestruction研究藥品銷毀investigator研究者investigatorbrochure研究者手冊IRB機構審評委員會IRB/IECapproval/favourableopinionIRB/

19、IEC批準/贊成意見lackofapproval未批準largesimpletrials擴大的無對照研究late-breakinginformation近期揭示的信息lead-inperiod導入期legallyacceptablerepresentative合法的代表lifetableanalysis生命表分析法life-threatening危及生命的linear線性的MAHcasereferencenumberMAH病例參考號MarketingAuthorizationHolders(MAH)上市審批機構marketauthorizationstatus獲準上市狀況marketedmed

20、icines上市藥物marketingauthorizationdossier獲準上市的資料（案卷）marketingauthorization上市許可marketingdrug上市藥物marketinglicense上市執照matrixgraph矩陣圖maximumeffectivedose最大有效劑量medicalcriteria醫學標準medicinalproduct醫療用品medwatch嚴重不良反應通知書meta-analysis薈萃分析minimumeffectivedose最小有效劑量missingdata缺失數據monitoring監察monitoringreport監察報告m

21、orbidity發病率mortality死亡率multicentrestudy多中心研究multicentretrial多中心試驗multiplecontrolgroups多重對照組multipleendpoints多重終點multivariate多變性namedpatientbasis具名病例的基礎NDAnumber新藥申請編號negative(unfavorable)effects負（不利的）效應newdosageforms新劑型newMolecularEntity新的分子化合物newregion新區域newlyanalyzedcompany-sponsoredstudies取新分析的公司

22、主辦研究notreatmentconcurrentcontrol非治療并行對照nonclinicalstudy非臨床研究non-concurrentlycontrolledstudy非并行對照研究non-inferioritytrial非劣效性試驗non-life-threatening無生命威脅nursinghome福利院nursingwomen哺乳婦女officiallabeling官方認可的用藥指南on-off-ondesign交叉設計optionaltitration供選擇的劑量滴定organtoxicitymonitoringcentre器官毒性監察中心originalmedical

23、record原始醫學記錄originatinginvestigator一線研究者overalleffect整體療效overlap重疊pair-wisecomparison成對比較paper-basedformats書面格式parallelgroupdesign平行設計parent-child/fetusreport父母-兒童/胎兒報告Patientexposure病人接觸藥物patientoutcome病人結局patient-days病人-天patientsatrisk處危病人perprotocolset(validcase,efficacysample；)符合試驗方案的對象數據集period

24、icsafetyupdatereports(PSUR)定期安全性更新報告Pharmaceuticalproduct（試驗）藥品pharmacodynamicresponse藥效學反應pharmacodynamics藥效學；藥效動力學pharmacoeconomics藥物經濟學pharmacoepidemiology藥物流行病學pharmacokinetic藥動學的pharmacokineticscreen藥物動力學篩選（方法）pharmacologicalproperties藥理學性質pharmacologicallyactivecompound藥理活性化合物pilottrial預初試驗pla

25、cebo安慰劑placeboconcurrentcontrol安慰劑并行對照placebo-controlledtitrationstudy安慰劑對照的劑量滴定研究placebo-controlledtrial安慰劑對照試驗plateau平臺期poisoncontrolcenter毒物控制中心polymorphism多態性populationexposure人群暴露populationmethod群體研究方法populationpharmacokineticmethods群體藥動學研究populationrepresentativeofthenewregion新區域的人群代表positive(

26、favorable)effects正（有利的）效應positiveslope正斜率postmarketingclinicalsafetyreporting上市后臨床安全性報告power把握度pre-approvalclinicalexperience批準前的臨床經驗precaution注意事項（在說明書中用）preferredandincludedterms首選和涵蓋術語premarketingclinicalsafetyreporting上市前臨床安全性報告prematureterminationorsuspensionofatrial試驗的中止或暫停;提前終止或暫停試驗preparedos

27、age準備用量primarysource最初來源prioritydrugs首選藥物procedures程序protocol試驗方案protocolamendment試驗方案的修改qualityassurance(QA)質量保證（QA）qualitycontrol(QC)質量控制（QC）quantitativeanalysis定量分析randomization隨機化randomizedparalleleddose-responsestudy隨機平仃量效研究randomizedwithdrawalstudy隨機撤藥研究rapidtransmission快速傳遞rateofoccurrence發生率

28、reasonablecausalrelationship合理的因果關系recordaccess查閱記錄referencesafetyinformation供參考的安全性資料regimen治療方案regionalregulation區域性法規regulatoryagency管理部門regulatoryauthority管理當局regulatoryauthority-generatedADRregistries管理當局的不良反應登記regulatorybodies管理部門regulatorycode管理編碼repeateddose重復給藥replacementstudy置換治療研究reproduc

29、tivetoxicity生殖毒性resolved減輕responsevariables效應變量retaintheblind維持盲態retrospectively回顧性地reversibilityofeffects作用的可逆性risk-benefitassessment風險受益評價routeofadministration給藥途徑safety&tolerability安全性和耐受性safetyendpoint安全性終占1-|L-、八、safetysummary安全性概要sample樣本screening篩選secondarysource次要來源sensitivity敏感性；靈敏度sensitiv

30、ity-to-drug-effects藥效靈敏度sequelae后遺癥sequentialdesign序貫設計seriousadversedrugreaction危重藥物不良反應seriousadverseevent(SAE)危重不良反應事件seriousness危重程度severe嚴重程度shifttable移仃表sideeffects副作用significantdisability嚴重的殘疾singledose單次給藥slopeanalysis斜率分析法sourcedata源數據sourcedocuments源文件sponsor申辦者sponsor-investigator申辦，研究者spuriousdata不合邏輯的數據StandardOperatingProcedures(SOP)標準操作規程startingdose起始劑量statisticalanalysisplan統計分析計劃steady-state穩態（血藥濃度）stratificationorblockingprocedures分層或劃塊法studyperiod試驗期studypopulation研究人群subeffectivedose亞有效劑量subinvestigator合作研究者