1、药品生产质量管理规范IB Investigators Brochure 研究者手册IC Informed Consent 知情同意ICF Informed Consent Form 知情同意书ICH International Conference on Harmonization 国际协调会议IDM Independent Data Monitoring 独立数据监察IDMC Independent Data Monitoring Committee 独立数据监察委员会IEC Independent Ethics Committee 独立伦理委员会IND Investigational Ne
2、w Drug 新药临床研究IRB Institutional Review Board 机构审查委员会IVD In Vitro Diagnostic 体外诊断IVRS Interactive Voice Response System 互动语音应答系统MA Marketing Approval/Authorization 上市许可证MCA Medicines Control Agency 英国药品监督局MHW Ministry of Health and Welfare 日本卫生福利部NDA New Drug Application 新药申请NEC New Drug Entity 新化学实体N
3、IH National Institutes of Health 国家卫生研究所（美国）PI Principal Investigator 主要研究者PL Product License 产品许可证PMA Pre-market Approval （Application） 上市前许可（申请）PSI Statisticians in the Pharmaceutical Industry 制药业统计学家协会QA Quality Assurance 质量保证QC Quality Control 质量控制RA Regulatory Authorities 监督管理部门SA Site Assessme
4、nt 现场评估SAE Serious Adverse Event 严重不良事件SAP Statistical Analysis Plan 统计分析计划SAR Serious Adverse Reaction 严重不良反应SD Source Data/Document 原始数据/文件Subject Diary 受试者日记SFDA State Food and Drug Administration 国家食品药品监督管理局SDV Source Data Verification 原始数据核准SEL Subject Enrollment Log 受试者入选表SI Sub-investigator S
5、ponsor-Investigator 申办研究者SIC Subject Identification Code 受试者识别代码SOP Standard Operating Procedure 标准操作规程SPL Study Personnel List 研究人员名单SSL Subject Screening Log 受试者筛选表T&R Test and Reference Product 受试和参比试剂UAE Unexpected Adverse Event 预料外不良事件WHO World Health Organization 世界卫生组织WHO-ICDRAWHO Internation
6、al Conference of Drug Regulatory AuthoritiesWHO国际药品管理当局会议 英文全称 Accuracy准确度Active control, AC阳性对照 活性对照Adverse drug reaction, ADRAdverse event, AEAdverse medical events不良医学事件Adverse reactionAlb白蛋白ALD（Approximate Lethal Dose）近似致死剂量ALP碱性磷酸酶Alpha spending function消耗函数ALT丙氨酸氨基转换酶Analysis sets统计分析的数据集Appro
7、val批准Assistant investigatorAST天门冬酸氨基转换酶ATR衰减全反射法AUCss稳态血药浓度时间曲线下面积Audit 稽查Audit or inspection稽查视察Audit report 稽查报告Auditor稽查员Bias偏性 偏倚Bioequivalence生物等效应Blank control空白对照Blind codes编制盲底Blind review盲态审核 盲态检查Blinding method盲法Blinding/masking盲法/设盲Block层Block size每段的长度Carryover effect延滞效应Case history病历Ca
8、se report form/ case record form CRF 病例报告表病例记录表Categorical variable分类变量Cav平均浓度CD 圆二色谱CL清除率Clinical equivalence临床等效应Clinical study临床研究Clinical study report临床试验的总结报告Clinical trial临床试验Clinical trial application CTA 临床试验申请Clinical trial exemption CTXClinical trial protocol CTPClinical trial/ study repor
9、t 临床试验报告Cmax峰浓度Comparison对照Compliance依从性Composite variable复合变量Computer-assisted trial design CATD计算机辅助试验设计Confidence interval可信区间Confidence level置信水平Consistency test 一致性检验Contract research organization CROContract/ agreement协议合同Control group对照组Coordinating committee 协调委员会Crea肌酐CRF（case report form）病
10、例报告表Crossover design交叉设计Cross-over Study交叉研究Css 稳浓度Cure痊愈Data management数据管理Database建立数据库Descriptive statistical analysis描述性统计分析DF波动系统Dichotomies 二分类Diviation 偏差Documentation记录文件Dose-reaction relation 剂量反应关系Double dummy双模拟Double dummy technique双盲双模拟技术Drop out 脱落DSC 差示扫描热量计Effectiveness疗效Electronic d
11、ata capture EDCElectronic data processing EDP 电子数据处理系统Emergency envelope应急信件End point终点Endpoint Criteria终点指标Endpoint criteria/ measurement 终点指标Equivalence 等效性Essential Documentation必需文件Ethics committee 伦理委员会Excellent显效Exclusion criteria排除标准Factorial design析因设计Failure无效 失败Final pointFixed-dose proced
12、ure固定剂量法Forced titration强制滴定Full analysis set全分析集GCFTIR气相色谱傅利叶红外联用GCMS 气相色谱质谱联用Generic drug 通用名药Global assessment variable全局评价变量GLU 血糖Good clinical practice, GCPGood manufacture practice, GMP 药品生产质量管理规范Good non-clinical laboratory practice, GLP 药物非临床研究质量管理规范Group sequential design成组序贯设计Health econom
13、ic evaluation, HEV健康经济学评价Hypothesis test假设检验Hypothesis testingImprovement好转Inclusion Criteria入选表准Inclusion criteria 入选标准Independent ethics committee IEC 独立伦理委员会Information consent form ICFInformation Gathering信息收集Informed consent ICInitial meeting启动会议Inspection检察/视察Institution inspection 机构检查Institu
14、tion review board, IBR 机构审查委员会Intention-to treat ITT意向性分析（ 统计学）Interactive voice response system IVRS 互动式语音应答系统Interim analysis期中分析International Conference of Harmonization ICH人用药品注册技术要求国际技术协调会 国际协调会议Investigational Product试验药物Investigator研究者Investigators brochure, IBLast observation carry forward,
15、LOCF最接近一次观察的结转LCMS 液相色谱质谱联用LD50 板数致死剂量LOCF, Last observation carry forward最近一次观察的结转Logic check逻辑检查LOQ （Limit of Quantization）定量限Lost of follow up失访Marketing approval/ authorizationMatched pair匹配配对Missing value缺失值Mixed effect model混合效应模式Monitor监察员Monitoring监查Monitoring Plan监察计划Monitoring Report监察报告MR
16、T平均滞留时间MS质谱MSMS质谱质谱联用MTD（Maximum Tolerated Dose） 最大耐受剂量Multi-center Trial多中心试验New chemical entity NCENew drug application NDA 新药申请NMR 核磁共振谱Non-clinical Study非临床研究Non-inferiority非劣效性Non-parametric statistics 非参数统计方法ObedienceODR 旋光光谱Open-label非盲Optional titration随意滴定Original medical record原始医疗记录Outcom
17、e 结果Outcome Assessment结果评价Outcome assessment结果指标评价Outcome measurement 结果指标Outlier离群值Parallel group design平行组设计Parameter estimation 参数估计Parametric statistics参数统计方法Patient file病人档案Patient historyPer protocol PP 符合方案集Placebo安慰剂Placebo control安慰剂对照Polytomies多分类Power检验效能Precision精密度Preclinical study临床前研究
18、Primary endpoint主要终点Primary variable主要变量Principle investigator PIProduct license PLProtocol试验方案Protocol Amendments修正案Quality assurance QAQuality assurance unit QAU 质量保证部门Quality control QCQuery list query form 应用疑问表Randomization随机Range check范围检查Rating scale量表Reference Product参比制剂Regulatory authoriti
19、es RAReplication可重复RSD日内和日间相对标准差Run in准备期Safety evaluation安全性评价Safety set安全性评价的数据集Sample size 样本量样本大小Scale of ordered categorical ratings 有序分类指标Secondary variable次要变量Sequence 试验次序Serious adverse event SAE 严重不良事件Serious adverse reaction SAR 严重不良反应Seriousness严重性Severity严重程度 严重程度Significant level检验水准Si
20、mple Randomization简单随机Single blinding 单盲Site audit 试验机构稽查SOP 试验室的标准操作规程Source data SD原始数据Source data verification SDVSource document SD 原始文件Specificity 特异性Sponsor申办者Sponsor-investigatorStandard curve标准曲线Standard operating procedure SOPStatistic 统计量Statistical analysis planStatistical model统计模型Statis
21、tical tables 统计分析表Stratified分层Study Audit研究稽查Study audit 研究稽查Study Site研究中心Subgroup 亚组Sub-investigator 助理研究者Subject受试者Subject diarySubject Enrollment受试者入选Subject enrollment logSubject identification code SIC 受试者识别代码Subject Identification Code List受试者识别代码表Subject Recruitment受试者招募Subject screening log
22、Superiority 检验Survival analysis生存分析SXRD单晶X射线衍射System audit系统稽查System Audit T1/2消除半衰期Target variable目标变量TBIL总胆红素TCHO总胆固醇Test Product受试制剂TG 热重分析TLC、HPLC制备色谱Tmax 峰时间TP总蛋白Transformation 变量变换Treatment group试验组Trial error 试验误差Trial Initial Meeting 试验启动会议Trial Master File试验总档案Trial objective试验目的Trial site
23、试验场所Triple blinding三盲Two one-side test 双单侧检验Un-blinding 揭盲Unexpected adverse event UAEUVVIS紫外可见吸收光谱Variability变异Variable变量Visual analogy scale直观类比打分法Visual check人工检查Vulnerable subject弱势受试者Wash-out洗脱Washout period洗脱期 实验室检查英文缩写英文全称血常规WBC white blood cell count白细胞计数 GR% granulocyte中性粒细胞百分比 LY% lymphocy
24、te 淋巴细胞百分比 MID% 中值细胞百分比 EOS% eosimophil 嗜酸性粒细胞百分比 AL% allergy lymphocyte 变异淋巴细胞百分比 ST% 中性杆状粒细胞百分比 RBC red blood cell 红细胞计数 HGB hemoglobin 血红蛋白 HCT hematocrit 红细胞比积 红细胞比积MCV mean corpusular volume平均红细胞体积 MCH mean corpusular hemoglobin平均红细胞血红蛋白含量 MCHC mean corpusular hemoglobin concerntration 平均红细胞血红蛋白浓度 RDW red blood cell volume distribution width 红细胞分布宽度变异 PLT/BPC
