ICH临床部分术语表

实用文档ICH临床部分术语表英文中文activecomparatortreatment阳性对照治疗activedose有效剂量activeplacebotreatment阳性安慰剂治疗activetreatmentconcurrentcontrol阳性药物并行对照adaptiveallocation适应性分组法addendum附件add-onstudy在标准治疗基础上的对照试验adjustdosage调整剂量adjustmentsforcovariates协变量调整administrationinstruction用药指南administrativecriteria用药标准adoption采用adverseconsequence不良后果adversedrugevents(ADE)药物不良事件adversedrugreaction(ADR)药物不良反应adverseevent(AE)不良事件adverseexperience不良经验agonist激动剂alertevent警告事件allocationwithsites临床试验点分配法Amendment(totheprotocol)修改（试验方案）ANCOVA协方差分析antagonist拮抗剂applicablelawsandregulations适用的法律和法规applicableregulatoryrequirement适用的管理条例applicationdossier申报资料approval批准approvedformarketing批准上市assaysensitivity检测方法的灵敏度assessment评估audit稽查auditcertificate稽查证书auditreport稽查报告audittrail稽查过程authorizationrenewal授权更新authorized授权authorizedwithqualification颁发许可证averagedose-responsecurve平均量效曲线backupofthedata数据备份实用文档baseline-controlledstudies基线对照研究batchnumber批号bayesianapproaches贝叶斯方法benefit/riskratio利益／风险比例bias偏差biometrics生物统计birthdefect出生缺陷blindreview盲态检查blinding盲法blinding/masking设盲blockdesign区组设计blood-levelpeaks血药峰值brandname商品名breaktheblind破盲bridgingdatapackage跨越数据集bridgingstudy跨越研究bulksales批量销售carcinogenicity致癌性carry-overeffect持续效应casereportform(CRF)病例报告表categoricalvariable分类变量causalrelationship因果关系Centralizedallocation集中分配法changefrombaselineresponse基线反应变换法CIOMS国际医学科学组织理事会clinicaldrugdevelopment临床药物开发clinicalresponse临床反应clinicalsafety临床安全性clinicalsafetydatamanagement临床安全性资料管理clinicalsafetyinformation临床安全性信息clinicaltrial/study临床试验/研究combinationtherapy联合治疗committeeforproprietarymedicalproducts专利医药产品委员会companycoredatasheet(CCDS)公司核心资料表companycoresafetyinformation(CCSI)公司核心安全性信息comparabilityoftestgroups试验组间的可比性comparativeeffectivenessstudies有效性的比较研究comparator对照剂comparator(product)对照（药物）compassionateuse照顾性应用实用文档completeclinicaldatapackage完整的临床资料集compliance依从性compoundsinsensitivetoethnicfactors对种族因素不敏的药物concentration-responsevalues浓度—效应值concentration-controlledstudy浓度控制研究concentration-responserelationship浓度—效应关系concomitantmedications伴随用药concurrentcontrol并行对照confidentiality保密性confirmatorystudy确认性研究congenitalabnormaly先天性异常consentform知情同意书contentvalidity内容的确实性contract合同contractresearchorganization(CRO)合同研究机构contraindication禁忌证controldrug对照药controlledtrials对照试验controlledvocabularies对照词汇CoordinatingCommittee协调委员会coordinatinginvestigator协调研究者copiesappended副本countryentries参与国家的名单covariateeffect协受欢应coxregressionoutput回归分析法criteriafortheterminationofthetrial终止试验的标准crossovercontrol交叉对照crossoverrdesign交叉设计cross-overstudy交叉研究cross-referencing交叉参阅CTXnumberCIX编号cumulativedose蓄积剂量database数据库dataelement数据要素dataentryandprocessing数据输入和处理datalockpoint数据锁定点demographiccharacteristics人口学特征directaccess直接接触documentation文件dosage剂量dosageform剂型实用文档dosagestrength规格dosecomparisonconcurrentcontrol剂量比较的并行对照doseinterval剂量间隔doserange剂量范围doseregimen给药方案dosetitration剂量滴定dose-responsecurve量效曲线dose-responseinformation量效关系资料dose-responserelationship量效关系dose-responseslope量效斜率dose-responsesurface量效关系面dose-tolerancestudy剂量—耐受性研究dosinginformation剂量信息double-blind双盲double-blindstudy双盲试验double-dummy双模拟dropout中途退出drugabuse药物滥用drugdependence药物依赖drugdevelop药物开发drugexposurelevel药物的暴露水平druginteraction药物相互作用drugmisuse药物误用drugregistration药物注册drug-concentration药物浓度durationofdosing用药时间earlyescape（无效治疗后）及早脱离effectiveness有效性electronicdataprocessingsystem(s)电子数据处理系统ENS-CAREsinglecaseformENS-CARE个案表格equivalencetrial等效性试验estimates预估值ESTRI(ICHelectronicstandardsforthetransferofregulatoryinformation)ICH管理信息传递的电子类标准ethicscommittee伦理委员会ethnicfactors种族因素EuroSCaPEformatEuroSCaPE研究格式evaluationofsafety安全性评价eventterms事件术语expedited(alert)report快速报告expirationdate失效期实用文档exploratorystudy探索性研究extendedexposure延长治疗external(historical)control回顾性对照extrapolationofforeignclinicaldata国外临床资料的延用factorialdesigns析因设计factorialtrial析因试验fatal致命的filetransfer档案转换finalreport总结报告fixeddose固定剂量forcedtitration强制性剂量滴定foreignclinicaldata国外临床资料freetext自由格式文本frequencyofdosing给药频率frequentistmethods频率论方法fullanalysisset完整的数据分析集fulltext全文本GCP临床试验管理规范generalisability,generalisation广义性genotoxicity遗传毒性geriatricpopulation老年人群geriatrics老年病学globalassessmentvariable总体评价变量glossaryofspecialterms特殊术语表GoodClinicalPractice(GCP)临床试验管理规范groupmean组均值groupsequentialdesigns成组序贯设计half-life半衰期harmonisedregulatorystandard协调管理标准healingrate治愈率historicalcontrol回顾性对照homogeneouspatient群体均一的病人humanpharmacology人体药理学hysteresis滞后现象ICHprocessICH程序ICHregionsICH区域ICHsteeringcommitteeICH指导委员会identifier鉴定impartialwitness公平的见证人improve改善incapacity机能不全；无能力实用文档IND研究性的新药INDnumberIND编号independentdata-monitoringcommittee(IDMC)独立的数据监察委员会independentethicscommittee(IEC)独立的伦理委员会individualcasesafetyreports个例安全性报告individualcharacteristics个体特征individualdifferences个体差异InternationalConferenceonHarmonisation(ICH)国际协调会议informedconsent知情同意informedconsentform知情同意书inspection视察institution(medical)（医学）研究机构institutionalrenewboard(IRB)机构审评委员会insurancestatement保险说明intensity(severity)严重程度；强度intention-to-treatprinciple治疗意向原则interaction相互作用interimanalysis中期分析InternationalBirthdate(IBD)国际首次上市日InternationalCommitteeofMedicalJourna