知识分享|国际药物注册英语词汇

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国际药物注册英语词汇


FDA(food and drug administration):(美国)食品药品监督管理局


NDA(new drug application):新药申请


ANDA(abbreviated new drug application):简化新药申请


EP(export application):出口药申请(申请出口不被批准在美国销售的药品)


treatment IND:研究中的新药用于治疗


abbreviated(new)drug:简化申请的新药


DMF(drug master file):药物主文件(持有者为谨慎起见而准备的保密资料,可以包括一个或多个人用药物在制备、加工、包装和贮存过程中所涉及的设备、生产过程或物品。只有在DMF持有者或授权代表以授权书的形式授权给FDA,FDA在审查IND、NDA、ANDA时才能参考其内容)


holder:DMF持有者


CFR(code of federal regulation):(美国)联邦法规


PANEL:专家小组


batch production:批量生产;分批生产


batch production records:生产批号记录


post or pre-market surveillance:销售前或销售后监督


informed consent:知情同意(患者对治疗或受试者对医疗试验了解后表示同意接受治疗或试验)


prescription drug:处方药


OTC drug(over—the—counter drug):非处方药


U.S. public health service:美国卫生福利部


NIH(national institute of health):(美国)全国卫生研究所


animal trail:动物试验


accelerated approval:加速批准


standard drug:标准药物


investigator :研究人员;调研人员


preparing and submitting:起草和申报


submission:申报;递交


benefit(s):受益


risk(s):受害


drug product:药物产品


drug substance:原料药


established name:确定的名称


generic name:非专利名称


proprietary name:专有名称;


INN(international nonproprietary name):国际非专有名称


narrative summary: 记叙体概要


adverse effect:副作用


adverse reaction:不良反应


protocol:方案


archival copy:存档用副本


review copy:审查用副本


official compendium:法定药典(主要指USP、 NF).


USP(the united state pharmacopeia):美国药典(现已和NF合并一起出版)


NF(national formulary):(美国)国家药品集


official=pharmacopeial = compendial:药典的;法定的;官方的


agency:审理部门(指FDA)


sponsor:主办者(指负责并着手临床研究者)


identity:真伪;鉴别;特性


strength:规格;规格含量(每一剂量单位所含有效成分的量)


labeled amount:标示量


regulatory specification:质量管理规格标准(NDA提供)


regulatory methodology:质量管理方法(FDA用于考核原料药或药物产品是否符合批准了的质量管理规格标准的整套步骤)


regulatory methods validation:管理用分析方法的验证(FDA对NDA提供的方法进行验证)


Dietary supplement:食用补充品


ICH(International Conference on Harmonization of Technical Requirements for Registration of Pharmaceuticals for Human Use)人用药物注册技术要求国际协调会议


ICH:Quality-质量


Q1A(R2): Stability Testing of New Drug Substances and Products (Second


Revision)


新原料药和制剂的稳定性试验(第二版)


Q1B: Photostability Testing of New Drug Substances and Products


新原料药和制剂的光稳定性试验


Q1C: Stability Testing for New Dosage Forms


新制剂的稳定性试验


Q1D: Bracketing and Matrixing Designs for Stability Testing of Drug


Substances and Drug Products


原料药和制剂稳定性试验的交叉和矩阵设计


Q1E: Evaluation of Stability Data


对稳定性数据的评估处理


Q1F: Stability Data Package for Registration Applications in Climatic


Zones III and IV


在气候带III和IV,药物注册申请所提供的稳定性数据


Q2A: Text on Validation of Analytical Procedures


分析程序的验证


Q2B: Validation of Analytical Procedures: Methodology


分析程序的验证:方法学


Q3A(R): Impurities in New Drug Substances (Revised Guideline)


新原料药中的杂质(修订版)


Q3B(R): Impurities in New Drug Products (Revised Guideline)


新制剂中的杂质(修订版)


Q3C: Impurities: Guideline for Residual Solvents


杂质:残留溶剂指南


Q3C(M): Impurities: Guideline for Residual Solvents (Maintenance)


杂质:残留溶剂指南(修改内容)


Q4: Pharmacopoeias药典


Q4A: Pharmacopoeial Harmonisation 药典的协调


Q4B: Regulatory Acceptance of Pharmacopoeial Interchangeability


药典互替在法规上的可接受性


Q5A: Viral Safety Evaluation of Biotechnology Products Derived from Cell


Lines of Human or Animal Origin


来源于人或者动物细胞系的生物技术产品的病毒安全性评估


Q5B: Quality of Biotechnological Products: Analysis of the Expression


Construct in Cells Used for Production of r-DNA Derived Protein Products


生物技术产品的质量:源于重组DNA的蛋白质产品的生产中所用的细胞中的表达构建分析


Q5C: Quality of Biotechnological Products: Stability Testing of


Biotechnological/Biological Products


生物技术产品的质量:生物技术/生物产品的稳定性试验


Q5D: Derivation and Characterisation of Cell Substrates Used for


Production of Biotechnological/Biological Products


用于生产生物技术/生物产品的细胞底物的起源和特征描述


Q5E: Comparability of Biotechnological/Biological Products Subject to


Changes in Their Manufacturing Process


基于不同生产工艺的生物技术产品/生物产品的可比较性


Q6: Specifications for New Drug Substances and Products


新原料药和制剂的质量规格


Q6A: Specifications: Test Procedures and Acceptance Criteria for New Drug


Substances and New Drug Products: Chemical Substances


质量规格:新原料药和新制剂的检验程序和可接收标准:化学物质


Q6B: Specifications: Test Procedures and Acceptance Criteria for


Biotechnological/Biological Products


质量规格:生物技术/生物产品的检验程序和可接收标准


Q7: Good Manufacturing Practices for Pharmaceutical Ingredients


活性药物成份的GMP


Q7A: Good Manufacturing Practice Guide for Active Pharmaceutical


Ingredients


活性药物成份的GMP指南


Q8: Pharmaceutical Development


药物研发


Q9: Quality Risk Management


质量风险管理


ICH:Safety-安全


S1A: Guideline on the Need for Carcinogenicity Studies of Pharmaceuticals


药物致癌性研究需要的指南


S1B: Testing for Carcinogenicity of Pharmaceuticals


药物致癌性的检验


S1C: Dose Selection for Carcinogenicity Studies of Pharmaceuticals


药物致癌性研究之剂量选择


S1C(R): Addendum: Addition of a Limit Dose and Related Notes


附录:极限剂量和有关注释的的补充


S2A: Guidance on Specific Aspects of Regulatory Genotoxicity Tests for


Pharmaceuticals


受法规管辖的药物基因毒性检验的特定方面的指南


S2B: Genotoxicity: A Standard Battery for Genotoxicity Testing for


Pharmaceuticals


基因毒性:药物基因毒性检验的标准


S3A: Note for Guidance on Toxicokinetics: The Assessment of Systemic


Exposure in Toxicity Studies


毒物代谢动力学指南的注释:毒性研究中的全身性暴露量的评估S3B: Pharmacokinetics: Guidance for Repeated Dose Tissue DistributionStudies药物代谢动力学:重复剂量的组织分布研究指南S4: Single Dose Toxicity Tests


单剂量毒性检验


S4A: Duration of Chronic Toxicity Testing in Animals (Rodent and


Non-Rodent Toxicity Testing)


动物体内慢性毒性持续时间的检验(啮齿动物和非啮齿动物毒性检验)


S5A: Detection of Toxicity to Reproduction for Medicinal Products


药物对生殖发育的毒性的检验


S5B(M): Maintenance of the ICH Guideline on Toxicity to Male Fertility:


An Addendum to the Guideline on Detection of Toxicity to Reproduction for Medicinal Products


对男性生殖能力的毒性的指南的变动:药物对生殖发育的毒性的检验指南增加了一个附录


S6: Preclinical Safety Evaluation of Biotechnology-Derived Pharmaceuticals


生物技术生产的药物的临床前安全评价


S7A: Safety Pharmacology Studies for Human Pharmaceuticals


人用药的安全药理学研究


S7B: The Nonclinical Evaluation of the Potential for Delayed Ventricular


Repolarization


(QT Interval Prolongation) By Human Pharmaceuticals


药物延迟心室复极化(QT间期)潜在作用的非临床评价


S8: Immunotoxicology Studies for Human Pharmaceuticals


人用药免疫毒理学研究


M3(M): Maintenance of the ICH Guideline on Non-Clinical Safety Studies for the Conduct of Human Clinical Trials for Pharmaceuticals


药物的对人临床试验的非临床安全研究指南的变动


E-Efficacy(有效)


E1: The Extent of Population Exposure to Assess Clinical Safety for Drugs


Intended for Long-Term Treatment of Non-Life-Threatening Conditions


对用于无生命危险情况下长期治疗的药物进行临床安全评估的族群暴露量范围


E2A: Clinical Safety Data Management: Definitions and Standards for


Expedited Reporting


临床安全数据管理:速报制度的定义和标准


E2B(R): Revision of the E2B(M) ICH Guideline on Clinical Safety Data


Management Data Elements for Transmission of Individual Case Safety


Reports


个案安全报告送交的临床安全数据管理的数据要素指南(E2B(M))的修订版


E2B (M): Maintenance of the Clinical Safety Data Management including:


Data Elements for Transmission of Individual Case Safety Reports


临床安全数据管理的变动包括:个案安全报告送交的数据要素


E2B(M): Maintenance of the Clinical Safety Data Management including


Questions and Answers


临床安全数据管理的变动,包括问答


E2C: Clinical Safety Data Management: Periodic Safety Update Reports for


Marketed Drugs


临床安全数据管理:已上市药品的周期性安全数据更新报告


Addendum to E2C: Periodic Safety Update Reports for Marketed Drugs


E2C的附录:已上市药品的周期性安全数据更新报告


E2D: Post-Approval Safety Data Management: Definitions and Standards for Expedited Reporting


批准后的安全数据管理:速报制度的定义和标准


E2E: Pharmacovigilance Planning


药物警戒计划


E3: Structure and Content of Clinical Study Reports


临床研究报告的结构和内容


E4: Dose-Response Information to Support Drug Registration


支持药品注册的剂量-效应资料


E5: Ethnic Factors in the Acceptability of Foreign Clinical Data


引入海外临床数据时要考虑的人种因素


E6: Good Clinical Practice: Consolidated Guideline


GCP:良好的临床规范:统一的指南


E7: Studies in Support of Special Populations: Geriatrics


对特定族群的支持的研究:老人病学


E8: General Considerations for Clinical Trials


对临床试验的总的考虑


E9: Statistical Principles for Clinical Trials


临床试验的统计原则


E10: Choice of Control Group and Related Issues in Clinical Trials


临床试验中控制组和有关课题的选择


E11: Clinical Investigation of Medicinal Products in the Pediatric


Population


小儿科药物的临床调查


E12A: Principles for Clinical Evaluation of New Antihypertensive Drugs


新抗高血压药物的临床评价原则


E14: The Clinical Evaluation of QT/QTc Interval Prolongation and


Proarrhythmic Potential for Non-Antiarrhythmic Drugs


非抗心率失常药物的QT/QTc 间期和致心率失常潜在作用的临床评价


Multidisciplinary Guidelines 多学科兼容的指南


M1: Medical Terminology


医学术语


M2: Electronic Standards for Transmission of Regulatory Information


(ESTRI)


药政信息传递之电子标准


M3: Timing of Pre-clinical Studies in Relation to Clinical Trials (See


Safety Topics)


有关临床试验的临床前研究的时间安排


M4: The Common Technical Document (See CTD section for complete Status of the guidelines)


通用技术文件(见有关CTD章节)


M5: Data Elements and Standards for Drug Dictionaries


药物词典的数据要素和标准




临床试验常用的英文缩略语


TTP:time-to-progression 疾病进展时间


SAE:severity Adverse Event 严重不良事件


AE:Adverse Event 不良事件


SOP:Standard Operating Procedure 标准操作规程


CRF:Case Report form 病例报告表


DLT:剂量限制毒性


MTD:最大耐受剂量


KPS:Karnofsky Performance Status行为状态评分


CR:complete response完全缓解


PR:partial response部分缓解


SD:病情稳定


PD:progressive disease病情进展


CTC:常用药物毒性标准


IEC:independent ethics committee 独立伦理委员会


IRB :institutional review board 伦理委员会


CRA: 临床研究助理


CRO:Contract Research Organization 合同研究组织


DFS:Disease Free Survival 无病生存期


OS:(Overall Survival) 总生存时间


IC:Informed consent 知情同意


ADR:Adverse Drug Reaction 不良反应


GAP:Good Agricultural Practice 中药材种植管理规范 


GCP:Good Clinical Practice 药物临床试验质量管理规范  


GLP:Good Laboratory Practice 药品实验室管理规范  


GMP:Good Manufacturing Practice 药品生产质量管理规范  


GSP:Good Supply Practice 药品经营质量管理规范  


GUP:Good Use Practice 药品使用质量管理规范


PI :Principal investigator 主要研究者


CI:Co-inveatigator 合作研究者


SI :Sub-investigator 助理研究者


COI :Coordinating investigtor 协调研究者


DGMP:医疗器械生产质量管理规范


ICF: Informed consent form 知情同意书


RCT :randomized controlled trial, 随机对照试验


NRCCT:non-randomized concurrent controlled trial, 非随机同期对照试验


EBM:evidence-based medicine 循证医学


RCD:randomized cross-over disgn 随机交叉对照试验


HCT:historial control trial, 历史对照研究


RECIST:Response Evaluation Criteria In Solid Tumors. 实体瘤疗效反应的评价标准


QC:Quality Control质量控制


UADR:Unexpected Adverse Drug Reaction,非预期药物不良反应


发布于 2021-07-25 14:01

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