医药行业专业英语词汇Word文件下载.docx
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医药行业专业英语词汇Word文件下载.docx
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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)?
METHODOLOGY:
质量管理方法?
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?
Pharmaceuticals?
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?
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?
Ingrediet)?
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;
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?
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?
APPLICATION):
新药申请?
ANDA(ABBREVIATED?
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?
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?
处方药?
OTC?
DRUG(OVER—THE—COUNTER?
非处方药?
GMP文件常见缩写ABPI?
Association?
the?
British?
Industry?
ADR?
Adverse?
Drug?
Reaction?
AE?
Event?
AIM?
Active?
Ingredient?
Manufacturer?
ANDA?
Abbreviated?
New?
Application?
ANOVA?
Analysis?
Variance?
ASM:
Substance?
ManufacturerATC?
Anatomical?
Therapeutic?
Chemical?
ATX?
Animal?
Test?
Exemption?
Certificate?
BAN?
Approved?
Name?
BIRA?
Institute?
Regulatory?
Affairs?
BNF?
National?
Formulary?
BP?
Pharmacopoeia?
C?
A?
S?
Suitability?
CENTRE?
FOR?
EVALUATION?
(CDE)Centre?
Administration?
(CPA)?
CMS?
Concerned?
Member?
State?
CMS每个成员国?
COS?
CPMP?
Committee?
Proprietary?
Medicinal?
Products?
CRA?
Clinical?
Research?
Associate?
CRF?
Case?
Report?
Form?
CRO?
Contract?
Organisation?
CTA?
Trial?
CTC?
CTD?
Common?
Document?
CTX?
Trials?
DDD?
Defined?
Daily?
Dose?
DGC?
Global?
Comparison?
DIA?
Information?
DMF?
Master?
File?
Drug?
Branch?
(DR,?
Evaluation?
&
Division,?
CPAEDQM?
(European?
Directorate?
Quality?
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?
ELA?
Established?
Licence?
EMEA?
Medicines?
Agency?
Products)?
欧洲联盟药品评价机构EP?
EPAR?
Public?
Assessment?
Reports?
ESRA?
Society?
European?
Commission?
欧洲药典委员会FDAFDA?
Food?
and?
final?
evaluation?
report?
(FER)free?
sale?
certificates?
(FSCs)?
GCP?
Good?
Practice?
GCP药品临床研究管理规范?
GLP?
Laboratory?
药品临床前安全性研究质量管理规范?
GMP?
Manufacturing?
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?
Advisory?
(MAC)IB?
Investigators?
Brochure?
ICH?
International?
Harmonisation?
IDMC?
Independent?
Data-Monitoring?
IEC?
Ethics?
IND?
Investigational?
INN?
Non-proprietary?
International?
(ICH)?
IPC?
In?
Process?
Control?
IRB?
Institutional?
Review?
Board?
LICENCE?
HOLDERMA?
Marketing?
Authorisation?
MAA?
MAA上市申请?
MAH?
Holder?
销售许可持有者MCA?
MHW?
Ministry?
Health?
Welfare?
(Japan)?
MR?
Mutual?
Recognition?
MRA?
美国与欧盟的互认协议?
MRAs?
(Mutual?
Agreements)?
互相认证同意MRFG?
Facilitation?
Group?
MRP?
Procedure?
NAS?
NCE?
Entity?
NDA?
new?
chemical?
entities?
(NCEs)new?
drug?
applications?
(NDAs)NSAID?
Non?
Steroidal?
Anti?
Inflammatory?
NTA?
Notice?
To?
Applicants?
OOS?
Out?
Specification?
Over?
The?
Counter?
PAGB?
Great?
Britain?
Ph?
Eur?
PIL?
Patient?
Leaflet?
PL?
POM?
Prescription?
Only?
PRODUCT?
OWNERPSU?
Periodic?
Safety?
Updates?
QA?
Assurance?
QC?
RAJ?
Journal?
RMS?
Reference?
RMS相互认可另一成员国?
RSD?
Relative?
Standard?
Deviation?
Rx?
SAE?
Serious?
SMF?
Site?
SOP?
Operating?
(STANDARD?
OPERATION?
PROCEDURE)?
标准运作程序SPC/SmPC?
Summary?
Characteristics?
summary?
product?
characteristics(SPC)Therapeutic?
Goods?
(TGA)USP?
US?
VMF?
Veterinary?
VPC?
CommitteeA.A.A?
Addition?
Amendments?
增补和修订AC?
Air?
Conditioner?
空调器ADR?
药物不良反应AFDO?
Officials?
食品与药品官员协会(美国)ACC?
Accept?
接受AQL?
Acceptable?
Level?
合格质量标准ADNA?
简化的新药申请BOM?
Bill?
Material?
物料清单BPC?
pharmaceutical?
Chemiclls?
原料药CBER?
Center?
Biologics?
生物制品评价与研究中心CFU?
Colony?
Forming?
Unet?
菌落形成单位DMF?
药品管理档案CDER?
Cemter?
amd?
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?
Insepctor?
消费者安全调查员CLP?
Line?
在线清洗程序DAL?
Defect?
Action?
缺陷作用水平DEA?
Enforcement?
Adminestration?
管制药品管理DS?
Documentation?
Systim?
文件系统FDA?
食品与药品管理局(美国)GATT?
General?
Agreemernt?
Tariffs?
Trade?
关贸总协会GMP?
Gvp?
药品生质量管理规范GCP?
药品临床实验管理规范GLP?
实验室管理规范GSP?
Supply?
药品商业质量规范GRP?
Gook?
RaTAIL?
药品零业质量管理规范GAP?
Agriculture?
药材生产管理规范GVP?
Validation?
Prctice?
验证管理规范GUP?
Use?
药品重用规范HVAC?
Heating?
Ventilation?
Conditioning?
空调净化系统ISO?
Intematonal?
Organization?
Standardization?
车际标准化组织MOU?
Memorandum?
Understanding?
谅解备忘录PF?
Porduction?
生产记录用表格OTC?
(Drug)?
非处方药品PLA?
License?
产品许可申请QA?
质量保证QC?
质量控制QMP?
Management?
质量管理程序SDA?
国家药品监督管理局SMP?
Managmert?
标准管理程序SOP?
标准操作程序TQC?
Tatal?
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,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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