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医药行业专业英语词汇词典

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(INTERNATIONAL 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

OFFICIAL=PHARMACOPEIAL= COMPENDIAL:药典的;法定的;官方的

AGENCY:审理部门(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 Pharmaceuticals 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;Consignment (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 FILE):药物主文件(持有者为谨慎起见而准备的资料,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

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 Abbreviated 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 Pharmacopoeia

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 Case 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 Branch (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 Medicinal 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

GCP药品临床研究管理规

GLP Good Laboratory Practice

GLP 药品临床前安全性研究质量管理规

GMP Good Manufacturing Practice

GMP 药品生产质量管理规

GSP药品销售管理规

Health Sciences Authority (HSA)

HSA’s Medicines Advisory Committee (MAC)

IB Investigators Brochure

ICH International Conference for Harmonisation

IDMC Independent Data-Monitoring Committee

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

MAH 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) 互相認證同意

MRFG Mutual Recognition Facilitation Group

MRP Mutual Recognition Procedure

NAS New Active Substance

NCE 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 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 Event

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

A.A.A 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 Chemiclls 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 Procedure 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

GCP Good Clinical Practice 药品临床实验管理规

GLP Good Laboratory Practice 实验室管理规

GSP Good Supply Practice 药品商业质量规

GRP Gook RaTAIL Practice 药品零业质量管理规

GAP Good Agriculture Practice 药材生产管理规

GVP Gook Validation Prctice 验证管理规

GUP Gook Use Practice 药品重用规

HVAC Heating Ventilation Air Conditioning 空调净化系统

ISO Intematonal Organization for Standardization 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 Managmert 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

twin :孪生dual 双重的

3. tri :三,丙triangle三角triacylglycerol三酰甘油tricarboxylic acid cycle 三羧酸循环

4. quadri,quadru,quart,tetr,tetra:四quadrilateral四边的quadrivalent四价的quadruped四足动物tetrode四极管tetracycline四环素

5. pent,penta,quique五pentose戊糖pentagon五角形pentane戊烷quintuple 五倍的pentose戊

糖pentomer五邻粒

6. hex,hexa,sex 六hexose已糖hexapod六足动物hexapoda昆虫纲hexamer六聚体

7. hepta,sept 七heptane 庚烷heptose 庚糖heptoglobin七珠蛋白

8. oct八octpus 章鱼octagon八角形octane 辛烷octase 辛糖

9. enne,nona九nonapeptide 九肽enneahedron 九面体

10. deca,deka 十:decapod 十足目动物decahedron 十面体decagram 十克

11. hecto, 百hectometer百米hectoliter百升hectowatt 百瓦

12. kilo,千kilodalton (KD) 千道尔顿kilobase 千碱基kiloelectron volt 千电子伏特

13. deci,十分之一,分decimeter 分米decigram 十分之一克

14. centi,百分之一

15. milli,千分之一,毫millimole 毫摩(尔)milliliter 毫升

16. micro,百万分之一,微,微小,微量microgram微克microogranism微生物microecology微生态学micropipet微量移液器

17. nano十亿分之一,毫微,纳nanosecond十亿分之一秒nanometer纳米

18. demi,hemi,semi半demibariel 半桶hemicerebrum 大脑半球semiopaque半透明semi-allel半等位基因semi-conductor半导体

19. holo 全,整体,完全holoenzyme 全酶holoprotein全蛋白holocrine全(质分)泌

20. mega巨大,兆,百万megaspore大孢子,megabasse兆碱基megakaryocyte巨核细胞megavolt 兆伏megalopolitan特大城市

21. macro 大,巨大,多macrophage巨噬细胞macrogamete大配子macroelement常量元素macromolecular大分子

22. poly,multi,mult 多,复合polyacrylate聚丙烯酸酯polymerase 聚合酶multichain多链的multinucleate 多核的multicistronic mRNA多顺反子mRNA multicopy多拷贝

1 chrom颜色

chromophore生色团chromosome染色体chromatography色谱法

2 melan,melano,nigr 黑

melanoma黑素瘤melanin黑色素melanophore黑色素细胞

3 xantho,flavo,fla,flavi,lute黄

xanthophyl叶黄素xanthous黄色的,黄色人种xathine黄嘌呤flavin黄素flavone黄酮letein黄体素,叶黄素flavin adenine dinucleotide(FAD)黄素腺嘌呤二核苷酸

4 erythro, rub, rubrm, ruf,红

erythrocyte红细胞erythromycin红霉素erythropoitin(EPO)促红细胞生成素

5 chloro,chlor绿,氯

chlorophyll叶绿素chloride氯化物chloramphenicol氯霉素

6 cyan,cyano 蓝,青紫色,氰

cyanophyceae 蓝藻纲cyanobacteria蓝细菌cyanide氰化物

7 aur,glid,chrys金色

aureomycin金霉素chrysose 金藻淀粉chrysanthemum菊花glidstone 金沙石glid 镀金

8 leu,leuco,leuk,leuko,blan,alb无色,白色

leucine亮氨酸leukaemia=leucosis白血病bleaching powder漂白粉albomycin白霉素

四表示方位和程度的词素

1 endo,ento,,在

endocrine分泌endocytosis胞吞作用endogamy近亲繁殖endolysin溶素entoderm胚层

2 ec, ect, exc, extra 外,外面,表面

ectoblast外胚层ectoparasite 外寄生生物extract 抽取,浸出

3 meso 中,中间

mesosphere 中圈,中层mesoplast 中胚层质

4 intra,intro,inter 在,向

intra-allelic interaction 等位基因相互作用intracellular(细)胞的interurban城市之间

5 centri,centro,medi,mid 中心,中央,中间

centrifuge离心centriole 中心粒centrosome 中心体centrogeng着丝基因

6 epi,peri 上,外,旁

epidermal growth factor(EGF): 表皮生长因子epibranchial上鳃的perilune近月点

7 sub,suc,suf,sug 下,低,小

suborder 亚目submucosa粘膜下层subclone亚克隆subcellular亚细胞subsection小节,分部

8 super,supra 上,高,超

superconductor超导体superfluid 超流体superoxide 超氧化物supramolecular超分子的

9 hyper 超过,过多

hypersensitive 过敏的hyperelastic 超弹性的hypertension 高血压hyperploid 超倍体

10 hypo下,低,次

hypoglycaemia 低血糖hypotension低血压hypophysis脑下垂体

11 iso 等,相同,同

iso-osmotic等渗的isopod等足目动物isotope同位素

12 oligo,olig少,低,寡,狭

oligohaline 狭盐性oligogene寡基因oligomer寡聚体oligophagous寡食性oligarchy寡头*** 13 eury 多,宽,广

eurythermal 广温的euryhaline广盐性eurytopic species广幅种

14 ultr 超

ultra-acoustics 超声学ultra-structure超微结构ultroviolet紫外线

15 infra 下,低,远

infralittoral 潮下带,远岸的infrahuman类人生物infrared红外线的infrastructure基础结构,基本结构

五表示动物不同器官和组织的词素

1 cephal,capit,cran 头,头颅

2 cyte 细胞

3 carn,my,mya,myo,肉,肌肉

4 haem,haemat,hem,aem,sangul 血

5 soma,corp 体,身体

6 some,plast 体,颗粒

7 hepa,hepat 肝heparin 肝素hepatopancreas肝胰腺hepatocyte 肝细胞hepatoma肝癌

8 ren,nephr 肾adrnal肾上腺的nephridia肾管nephron肾单位

9 card,cord 心cardiotoxin 心脏毒素cardiovascular center 心血管中枢electrocardiogram心电图concord一致,和谐

10 ophthalm,ocell,ocul 眼ophthalmology眼科学ophthalmia眼炎ophthalmologist眼科专家