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医药行业专业英语词汇.docx

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医药行业专业英语词汇.docx

医药行业专业英语词汇

医药行业专业英语词汇（非常有用）

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:

GMPQ7a:

（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?

Ingrediet）?

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；Consignmecnt（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?

GMP文件常见缩写ABPI?

Association?

of?

the?

British?

Pharmaceutical?

Industry?

ADR?

Adverse?

Drug?

Reaction?

AE?

Adverse?

Event?

AIM?

Active?

Ingredient?

Manufacturer?

ANDA?

Abbreviated?

New?

Drug?

Application?

ANOVA?

Analysis?

of?

Variance?

ASM:

Active?

Substance?

ManufacturerATC?

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?

of?

Certificate?

of?

Analysis?

of?

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,?

CPAEDQM?

（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FDAFDA?

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）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?

HOLDERMA?

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）?

互相认证同意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?

OWNERPSU?

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?

CommitteeA．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?

药品生质量管理规范GCP?

Good?

Clinical?

Practice?

药品临床实验管理规范GLP?

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?

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?

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?

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,内，在内?

endocrine内分泌endocytosis胞吞作用?

endogamy近亲繁殖?

endolysin内溶素?

entoderm内胚层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,intr

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