医药行业专业英语词汇词典.pdf
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1、 FDA 和 EDQM 术语:CLINICAL TRIAL:临床试验 ANIMAL TRIAL: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 BENIFIT(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(I
2、NTERNATIONAL NONPROPRIETARY NAME):国际非专有名称 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 STATES PHARMACOPEIA):美国药典 NF(NATIONAL FORMULARY):(美国)国家处方集 OFFICIALPHARMACOPEIAL=COMPENDIAL:药典的;法定的;官方的 AGENCY:审理部门(
3、指 FDA)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 REGULATORY METHODS VALIDATION:管理用分析方法的验证 COS/CEP 欧洲药典符合性认证 ICH(International Conference on Harmonization of Technical Requirements for Registration of Pha
4、rmaceuticals for Human Use)人用药物注册技术要求国际协调会议 ICH 文件分为质量、安全性、有效性和综合学科 4 类。质量技术要求文件以 Q 开头,再以 a,b,c,d 代表小项:Q1:药品的稳定性 Q2:方法学 Q3:杂质 Q4:药典 Q5:生物技术产品质量 Q6:标准规格 Q7:GMP Q7a:(原料药的优良制造规范指南)药物活性成分的 GMP.GMP 英语 PIC/S 的全称为:Pharmaceutical Inspection Convention/Pharmaceutical Inspection Cooperation Scheme,PIC/S(制药检查草
5、案),药品检查协会(PIC/S),也有人称 PIC/S 为医药审查会议/合作计划(PIC/S)PIC 的权威翻译:药品生产检查相互承认公约 API(Active Pharmaceutical Ingredient)原料药 又称:活性药物组分 AirLock 气闸 Authorized Person 授权人 Batch/Lot 批次 Batch Number/Lot-Number 批号;Batch Numbering System 批次编码系统;Batch Records 批记录;Bulk Product 待包装品;Calibration 校正;Clean area 洁净区;Consignmen
6、t(Delivery)托销药品。FDA(FOOD AND DRUG ADMINISTRATION):(美国)食品药品管理局 IND(INVESTIGATIONAL NEW DRUG):临床研究申请(指申报阶段,相对于 NDA 而 言);研究中的新药(指新药开发阶段,相对于新药而言,即临床前研究结束)NDA(NEW DRUG APPLICATION):新药申请 ANDA(ABBREVIATED NEW DRUG APPLICATION):简化新药申请 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 FIL
7、E):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 I
8、NFORMED 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(OVERTHECOUNTER DRUG):非处方药 GMP 文件常见缩写 ABPI Association of the British Pharmaceutical Industry 英国制药工业协会 ADR Adverse Drug Reaction 药品不良反应 AE Adverse Event 不良事件,不良反应 AIM Active Ingredient Manufacturer 原料药制造商 ANDA Abbreviate
9、d New Drug Application 简化新药申请 ANOVA Analysis of Variance 方差分析 ASM:Active Substance Manufacturer 原料药制造商 ATC Anatomical Therapeutic Chemical ATX Animal Test Exemption Certificate BAN British Approved Name BIRA British Institute of Regulatory Affairs BNF British National Formulary BP British Pharmacopo
10、eia C of A Certificate of Analysis C of S Certificate of Suitability CENTRE FOR DRUG EVALUATION(CDE)Centre for Pharmaceutical Administration(CPA)CMS Concerned Member State CMS 每个成员国 COS Certificate of Suitability CPMP Committee for Proprietary Medicinal Products CRA Clinical Research Associate CRF C
11、ase Report Form CRO Contract Research Organisation CTA Clinical Trial Application CTC Clinical Trial Certificate CTD Common Technical Document CTX Clinical Trials Exemption DDD Defined Daily Dose DGC Daily Global Comparison DIA Drug Information Association DMF Drug Master File Drug Registration Bran
12、ch(DR,Product Evaluation&Registration Division,CPA EDQM(European Directorate for the Quality of Medicines)欧洲联盟药品质量指导委员会 EEA 欧洲经济地区 EGMA European Generics Medicine Association ELA Established Licence Application EMEA European Medicines Evaluation Agency EMEA(European Agency for the Evaluation of Medi
13、cinal Products)欧洲联盟药品评价机构 EP European Pharmacopoeia EPAR European Public Assessment Reports ESRA European Society of Regulatory Affairs European Pharmacopoeia Commission 欧洲药典委员会 FDA FDA Food and Drug Administration final evaluation report(FER)free sale certificates(FSCs)GCP Good Clinical Practice GC
14、P 药品临床研究管理规范 GLP Good Laboratory Practice GLP 药品临床前安全性研究质量管理规范 GMP Good Manufacturing Practice GMP 药品生产质量管理规范 GSP 药品销售管理规范 Health Sciences Authority(HSA)HSAs Medicines Advisory Committee(MAC)IB Investigators Brochure ICH International Conference for Harmonisation IDMC Independent Data-Monitoring Com
15、mittee IEC Independent Ethics Committee IND Investigational New Drug INN International Non-proprietary Name International Conference on Harmonisation(ICH)IPC In Process Control IRB Institutional Review Board LICENCE HOLDER MA Marketing Authorisation MAA Marketing Authorisation Application MAA 上市申请 M
16、AH Marketing Authorisation Holder MAH 销售许可持有者 MCA Medicines Control Agency MHW Ministry of Health and Welfare(Japan)MR Mutual Recognition MRA 美国与欧盟的互认协议 MRAs(Mutual Recognition Agreements)互相认证同意 MRFG Mutual Recognition Facilitation Group MRP Mutual Recognition Procedure NAS New Active Substance NCE
17、New Chemical Entity NDA New Drug Application new chemical entities(NCEs)new drug applications(NDAs)NSAID Non Steroidal Anti Inflammatory Drug NTA Notice To Applicants OOS Out of Specification OTC Over The Counter PAGB Proprietary Association of Great Britain Ph Eur European Pharmacopoeia PIL Patient
18、 Information Leaflet PL Product Licence POM Prescription Only Medicine PRODUCT OWNER PSU Periodic Safety Updates QA Quality Assurance QC Quality Control RAJ Regulatory Affairs Journal RMS Reference Member State RMS 相互认可另一成员国 RSD Relative Standard Deviation Rx Prescription Only SAE Serious Adverse Ev
19、ent SMF Site Master File SOP Standard Operating Procedure SOP(STANDARD OPERATION PROCEDURE)标准运作程序 SPC/SmPC Summary of Product Characteristics summary of product characteristics(SPC)Therapeutic Goods Administration(TGA)USP US Pharmacopoeia VMF Veterinary Master File VPC Veterinary Products Committee
20、AAA Addition and Amendments 增补和修订 AC Air Conditioner 空调器 ADR Adverse Drug Reaction 药物不良反应 AFDO Association of Food and Drug Officials 食品与药品官员协会(美国)ACC Accept 接受 AQL Acceptable Quality Level 合格质量标准 ADNA Abbreviated New Drug Application 简化的新药申请 BOM Bill of Material 物料清单 BPC Bulk pharmaceutical Chemicl
21、ls 原料药 CBER Center for Biologics Evaluation Research 生物制品评价与研究中心 CFU Colony Forming Unet 菌落形成单位 DMF Drug Master File 药品管理档案 CDER Cemter for Drug Evaluation amd Research 药物评价与研究中心 CI Corporate Identity(Image)企业识别(形象)CIP Cleaning in Place 在线清洗 CSI Consumer Safety Insepctor 消费者安全调查员 CLP Cleaning Line P
22、rocedure 在线清洗程序 DAL Defect Action Level 缺陷作用水平 DEA Drug Enforcement Adminestration 管制药品管理 DS Documentation Systim 文件系统 FDA Food and Drug Administration 食品与药品管理局(美国)GATT General Agreemernt on Tariffs and Trade 关贸总协会 GMP Good Manufacturing Practice Gvp 药品生质量管理规范 GCP Good Clinical Practice 药品临床实验管理规范 G
23、LP Good Laboratory Practice 实验室管理规范 GSP Good Supply Practice 药品商业质量规范 GRP Gook RaTAIL Practice 药品零业质量管理规范 GAP Good Agriculture Practice 药材生产管理规范 GVP Gook Validation Prctice 验证管理规范 GUP Gook Use Practice 药品重用规范 HVAC Heating Ventilation Air Conditioning 空调净化系统 ISO Intematonal Organization for Standardi
24、zation 车际标准化组织 MOU Memorandum of Understanding 谅解备忘录 PF Porduction File 生产记录用表格 OTC Over the Counter(Drug)非处方药品 PLA Product License Application 产品许可申请 QA Quality Assurance 质量保证 QC Quality Control 质量控制 QMP Quality Management Procedure 质量管理程序 SDA State Drug Administration 国家药品监督管理局 SMP Standard Managm
25、ert Procedure 标准管理程序 SOP Standard Operating Procedure 标准操作程序 TQC Tatal Quality Control 全面质量管理 USA Uneted States Pharmacopeia 美国药典 专业英语词汇词素(词根)1.haplo,mono,uni:单,一,独 haploid 单倍体 monoxide 一氧化碳 monoatomic 单原子的 2.bi,di,dipl,twi,du::二,双,两,偶 biocolor 双 色,dichromatic 双 色的,diplobacillus 双杆菌 dikaryon 双核体 twi
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