ICH临床部分术语表.doc

资料收集于网络，如有侵权请联系网站删除（二）对“碧芝”自制饰品店的分析ICH临床部分术语表英文中文active comparator treatment阳性对照治疗active dose有效剂量active placebo treatment阳性安慰剂治疗active treatment concurrent control阳性药物并行对照adaptive allocation适应性分组法addendum附件add-on study在标准治疗基础上的对照试验adjust dosage调整剂量adjustments for covariates协变量调整administration instruction用药指南administrative criteria用药标准adoption采用adverse consequence不良后果adverse drug events (ADE)药物不良事件adverse drug reaction (ADR)药物不良反应adverse event (AE)不良事件adverse experience不良经验agonist激动剂alert event警告事件allocation with sites临床试验点分配法Amendment (to the protocol)修改（试验方案）ANCOVA协方差分析antagonist拮抗剂applicable laws and regulations适用的法律和法规applicable regulatory requirement适用的管理条例application dossier申报资料approval批准approved for marketing批准上市assay sensitivity检测方法的灵敏度assessment评估audit稽查audit certificate稽查证书audit report稽查报告audit trail稽查过程authorization renewal授权更新authorized授权authorized with qualification颁发许可证average dose-response curve平均量效曲线backup of the data数据备份baseline-controlled studies基线对照研究batch number批号bayesian approaches贝叶斯方法benefit/risk ratio利益风险比例bias偏差biometrics生物统计birth defect出生缺陷blind review盲态检查blinding盲法blinding/masking设盲block design区组设计blood-level peaks血药峰值brand name商品名break the blind破盲bridging data package跨越数据集bridging study跨越研究bulk sales批量销售carcinogenicity致癌性carry-over effect持续效应case report form(CRF)病例报告表categorical variable分类变量causal relationship因果关系Centralized allocation集中分配法change from baseline response基线反应变换法CIOMS国际医学科学组织理事会clinical drug development临床药物开发clinical response临床反应clinical safety临床安全性clinical safety data management临床安全性资料管理clinical safety information临床安全性信息clinical trial/study临床试验/研究combination therapy联合治疗committee for proprietary medical products专利医药产品委员会company core data sheet (CCDS)公司核心资料表company core safety information(CCSI)公司核心安全性信息comparability of test groups试验组间的可比性comparative effectiveness studies有效性的比较研究comparator对照剂comparator(product)对照（药物）compassionate use照顾性应用complete clinical data package完整的临床资料集compliance依从性compounds insensitive to ethnic factors对种族因素不敏的药物concentration-response values浓度效应值concentration-controlled study浓度控制研究concentration-response relationship浓度效应关系concomitant medications伴随用药concurrent control并行对照confidentiality保密性confirmatory study确认性研究congenital abnormaly先天性异常consent form知情同意书content validity内容的确实性contract合同contract research organization (CRO)合同研究机构contraindication禁忌证control drug对照药controlled trials对照试验controlled vocabularies对照词汇Coordinating Committee协调委员会coordinating investigator协调研究者copies appended副本country entries参与国家的名单covariate effect协受欢应cox regression output回归分析法criteria for the termination of the trial终止试验的标准crossover control交叉对照crossoverr design交叉设计cross-over study交叉研究 cross-referencing交叉参阅CTX numberCIX编号cumulative dose蓄积剂量data base数据库data element数据要素data entry and processing数据输入和处理data lock point数据锁定点demographic characteristics人口学特征direct access直接接触documentation文件dosage剂量dosage form剂型dosage strength规格dose comparison concurrent control剂量比较的并行对照dose interval剂量间隔dose range剂量范围dose regimen给药方案dose titration剂量滴定dose-response curve量效曲线dose-response information量效关系资料dose-response relationship量效关系dose-response slope量效斜率dose-response surface量效关系面dose-tolerance study剂量耐受性研究dosing information剂量信息double-blind双盲double-blind study双盲试验double-dummy双模拟dropout中途退出drug abuse药物滥用drug dependence药物依赖drug develop药物开发drug exposure level药物的暴露水平drug interaction药物相互作用drug misuse药物误用drug registration药物注册drug-concentration药物浓度duration of dosing用药时间early escape（无效治疗后）及早脱离effectiveness有效性electronic data processing system(s)电子数据处理系统ENS-CARE single case formENS-CARE个案表格equivalence trial等效性试验estimates预估值ESTRI (ICH electronic standards for the transfer of regulatory information)ICH管理信息传递的电子类标准ethics committee伦理委员会ethnic factors种族因素EuroSCaPE formatEuroSCaPE研究格式evaluation of safety安全性评价event terms事件术语expedited (alert) report快速报告expiration date失效期exploratory study探索性研究extended exposure延长治疗external (historical) control回顾性对照extrapolation of foreign clinical data国外临床资料的延用factorial designs析因设计factorial trial析因试验fatal致命的file transfer档案转换final report总结报告fixed dose固定剂量forced titration强制性剂量滴定foreign clinical data国外临床资料free text自由格式文本frequency of dosing给药频率frequentist methods频率论方法full analysis set完整的数据分析集full text全文本GCP临床试验管理规范generalisability, generalisation广义性genotoxicity遗传毒性geriatric population老年人群geriatrics老年病学global assessment variable总体评价变量glossary of special terms特殊术语表Good Clinical Practice(GCP)临床试验管理规范group mean组均值group sequential designs成组序贯设计half-life半衰期harmonised regulatory standard协调管理标准healing rate治愈率historical control回顾性对照homogeneous patient群体均一的病人human pharmacology人体药理学hysteresis滞后现象ICH processICH程序ICH regionsICH区域ICH steering committeeICH指导委员会identifier鉴定impartial witness公平的见证人improve改善incapacity机能不全；无能力IND研究性的新药IND numberIND编号independent data-monitoring committee (IDMC)独立的数据监察委员会independent ethics committee (IEC)独立的伦理委员会individual case safety reports个例安全性报告individual characteristics个体特征individual differences个体差异International Conference on Harmonisation (ICH)国际协调会议informed consent知情同意informed consent form知情同意书inspection视察institution (medical)（医学）研究机构institutional renew board (IRB)机构审评委员会insurance statement保险说明intensity (severity)严重程度；强度intention-to-treat principle治疗意向原则interaction相互作用interim analysis中期分析International Birthdate (IBD)国际首次上市日International Committee of Medical Journal Editors医学杂志国际编辑委员会International Drug Monitoring Centre国际药物监测中心International-Non-Proprietary Name (INPN)国际非专用名inter-rater reliability评估者间的可靠性intervention干预intervention study干预性研究intra-rater reliability评估者内的可靠性intrinsic ethnic factors内在的种族因素in-use effectiveness使用有效性investigational products account-ability研究药品计数investigational product destruction研究药品销毁investigator研究者investigator brochure研究者手册IRB机构审评委员会IRB/IEC approval/favourable opinionIRBIEC批准赞成意见lack of approval未批准large simple trials扩大的无对照研究late-breaking information近期揭示的信息lead-in period导入期legally acceptable representative合法的代表life table analysis生命表分析法life-threatening危及生命的linear线性的MAH case reference numberMAH病例参考号Marketing Authorization Holders (MAH)上市审批机构market authorization status获准上市状况marketed medicines上市药物marketing authorization dossier获准上市的资料（案卷）marketing authorization上市许可marketing drug上市药物marketing license上市执照matrix graph矩阵图maximum effective dose最大有效剂量medical criteria医学标准medicinal product医疗用品medwatch严重不良反应通知书meta-analysis荟萃分析minimum effective dose最小有效剂量missing data缺失数据monitoring监察monitoring report监察报告morbidity发病率mortality死亡率multicentre study多中心研究multicentre trial多中心试验multiple control groups多重对照组multiple endpoints多重终点multivariate多变性named patient basis具名病例的基础NDA number新药申请编号negative (unfavorable) effects负（不利的）效应new dosage forms新剂型new Molecular Entity新的分子化合物new region新区域newly analyzed company-sponsored studies最新分析的公司主办研究no treatment concurrent control非治疗并行对照nonclinical study非临床研究non-concurrently controlled study非并行对照研究non-inferiority trial非劣效性试验non-life-threatening无生命威胁nursing home福利院nursing women哺乳妇女official labeling官方认可的用药指南on-off-on design交叉设计optional titration供选择的剂量滴定organ toxicity monitoring centre器官毒性监察中心original medical record原始医学记录originating investigator一线研究者overall effect整体疗效overlap重叠pair-wise comparison成对比较paper-based formats书面格式parallel group design平行设计parent-child/fetus report父母-儿童胎儿报告Patient exposure病人接触药物patient outcome病人结局patient-days病人-天patients at risk处危病人per protocol set (valid case，efficacy sample；)符合试验方案的对象数据集periodic safety update reports (PSUR)定期安全性更新报告Pharmaceutical product（试验）药品pharmacodynamic response药效学反应pharmacodynamics药效学；药效动力学pharmacoeconomics药物经济学pharmacoepidemiology药物流行病学pharmacokinetic药动学的pharmacokinetic screen药物动力学筛选（方法）pharmacological properties药理学性质pharmacologically active compound药理活性化合物pilot trial预初试验placebo安慰剂placebo concurrent control安慰剂并行对照placebo-controlled titration study安慰剂对照的剂量滴定研究placebo-controlled trial安慰剂对照试验plateau平台期poison control center毒物控制中心polymorphism多态性population exposure人群暴露population method群体研究方法population pharmacokinetic methods群体药动学研究population representative of the new region新区域的人群代表positive (favorable) effects正（有利的）效应positive slope正斜率postmarketing clinical safety reporting上市后临床安全性报告power把握度pre-approval clinical experience批准前的临床经验precaution注意事项（在说明书中用）preferred and included terms首选和涵盖术语premarketing clinical safety reporting上市前临床安全性报告premature termination or suspension of a trial试验的中止或暂停；提前终止或暂停试验prepare dosage准备用量primary source最初来源priority drugs首选药物procedures程序protocol试验方案protocol amendment试验方案的修改quality assurance(QA)质量保证（QA）quality control(QC)质量控制（QC）quantitative analysis定量分析randomization随机化randomized paralleled dose-response study随机平行量效研究randomized withdrawal study随机撤药研究rapid transmission快速传递rate of occurrence发生率reasonable causal relationship合理的因果关系record access查阅记录reference safety information供参考的安全性资料regimen治疗方案regional regulation区域性法规regulatory agency管理部门regulatory authority管理当局regulatory authority-generated ADR registries管理当局的不良反应登记regulatory bodies管理部门regulatory code管理编码repeated dose重复给药replacement study置换治疗研究reproductive toxicity生殖毒性resolved减轻response variables效应变量retain the blind维持盲态retrospectively回顾性地reversibility of effects作用的可逆性risk-benefit assessment风险受益评价route of administration给药途径safety & tolerability安全性和耐受性safety endpoint安全性终点safety summary安全性概要sample样本screening筛选secondary source次要来源sensitivity敏感性；灵敏度sensitivity-to-drug-effects药效灵敏度sequelae后遗症sequential design序贯设计serious adverse drug reaction危重药物不良反应serious adverse event (SAE)危重不良反应事件seriousness危重程度severe严重程度shift table移行表side effects副作用significant disability严重的残疾single dose单次给药slope analysis斜率分析法source data源数据source documents源文件sponsor申办者sponsor-investigator申办，研究者spurious data不合逻辑的数据Standard Operating Procedures (SOP)标准操作规程starting dose起始剂量statistical analysis plan统计分析计划steady-state稳态（血药浓度）stratification or blocking procedures分层或划块法study period试验期study population研究人群subeffective dose亚有效剂量subinvestigator合作研究