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 IndustryADR Adverse Drug ReactionAE Adverse EventAIM Active Ingredient ManufacturerANDA Abbreviated New Drug Application ANOVA Analysis of VarianceASM: Active Substance ManufacturerATC Anatomical Therapeutic ChemicalATX Animal Test Exemption CertificateBAN British Approved NameBIRA British Institute of Regulatory AffairsBNF British National FormularyBP British PharmacopoeiaC of A Certificate of AnalysisC of S Certificate of SuitabilityCENTRE FOR DRUG EVALUATION (CDE)Centre for Pharmaceutical Administration (CPA) CMS Concerned Member StateCMS每个成员国COS Certificate of SuitabilityCPMP Committee for Proprietary Medicinal Products CRA Clinical Research AssociateCRF Case Report FormCRO Contract Research OrganisationCTA Clinical Trial ApplicationCTC Clinical Trial CertificateCTD Common T echnical DocumentCTX Clinical Trials ExemptionDDD Defined Daily DoseDGC Daily Global ComparisonDIA Drug Information AssociationDMF Drug Master FileDrug 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 AssociationELA Established Licence ApplicationEMEA European Medicines Evaluation AgencyEMEA （European Agency for the Evaluation of Medicinal Products）欧洲联盟药品评价机构EP European PharmacopoeiaEPAR European Public Assessment ReportsESRA European Society of Regulatory AffairsEuropean Pharmacopoeia Commission 欧洲药典委员会FDAFDA Food and Drug Administrationfinal evaluation report (FER)free sale certificates (FSCs)GCP Good Clinical PracticeGCP药品临床研究管理规范GLP Good Laboratory PracticeGLP 药品临床前安全性研究质量管理规范GMP Good Manufacturing PracticeGMP 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 BrochureICH International Conference for Harmonisation IDMC Independent Data-Monitoring Committee IEC Independent Ethics CommitteeIND Investigational New DrugINN International Non-proprietary Name International Conference on Harmonisation (ICH) IPC In Process ControlIRB Institutional Review BoardLICENCE HOLDERMA Marketing AuthorisationMAA Marketing Authorisation ApplicationMAA上市申请MAH Marketing Authorisation HolderMAH 销售许可持有者MCA Medicines Control AgencyMHW Ministry of Health and Welfare (Japan)MR Mutual RecognitionMRA 美国与欧盟的互认协议MRAs (Mutual Recognition Agreements) 互相認證同意MRFG Mutual Recognition Facilitation GroupMRP Mutual Recognition ProcedureNAS New Active SubstanceNCE New Chemical EntityNDA New Drug Applicationnew chemical entities (NCEs)new drug applications (NDAs)NSAID Non Steroidal Anti Inflammatory DrugNTA Notice To ApplicantsOOS Out of SpecificationOTC Over The CounterPAGB Proprietary Association of Great BritainPh Eur European PharmacopoeiaPIL Patient Information LeafletPL Product LicencePOM Prescription Only MedicinePRODUCT OWNERPSU Periodic Safety UpdatesQA Quality AssuranceQC Quality ControlRAJ Regulatory Affairs JournalRMS Reference Member StateRMS相互认可另一成员国RSD Relative Standard DeviationRx Prescription OnlySAE Serious Adverse EventSMF Site Master FileSOP Standard Operating ProcedureSOP （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 PharmacopoeiaVMF Veterinary Master FileVPC 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 T ariffs 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,intro,inter 在内，向内intra-allelic interaction 等位基因内相互作用intracellular（细）胞内的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11 branchi 鳃filibranch丝鳃lamellibrnch瓣鳃sencondary branchium次生鳃12 brac ,brachi 腕，手臂brachiolaria 短腕幼虫brachionectin臂粘连蛋白bracelet手镯13 dent,odont 牙齿dentin牙质odontphora 齿舌odontoblast成牙质细胞14 plum羽plumatus 羽状的plumule绒毛plumage （鸟的）羽毛15 foli,foil 叶follicle滤泡foiling叶形foliage 叶子foliose 多叶的药名常用词首ace- 乙（酰基）acet- 醋；醋酸；乙酸acetamido- 乙酰胺基acetenyl- 乙炔基acetoxy- 醋酸基；乙酰氧基acetyl- 乙酰（基）. aetio- 初allo- 别allyl- 烯丙（基）；CH2=CH-CH2-amido- 酰胺（基）amino- 氨基amyl- ①淀粉②戊（基）amylo- 淀粉andr- 雄andro- 雄anilino- 苯胺基anisoyl- 茴香酰；甲氧苯酰anti- 抗apo- 阿朴；去水aryl- 芳（香）基aspartyl- 门冬氨酰auri- 金（基）；（三价）金基aza- 氮（杂）azido- 叠氮azo- 偶氮basi- 碱baso- 碱benxoyl- 苯酰；苯甲酰. benzyl- 苄（基）；苯甲酰bi- 二；双；重biphenyl- 联苯基biphenylyl- 联苯基bis- 双；二bor- 硼boro- 硼bromo- 溴butenyl- 丁烯基（有1、2、3位三种）butoxyl- 丁氧基butyl- 丁基butyryl- 丁酰caprinoyl- 癸酰caproyl- 己酰calc- 钙calci- 钙calco- 钙capryl- 癸酰capryloyl- 辛酰caprylyl- 辛酰cef- 头孢（头孢菌素族抗生素词首）chlor- ①氯②绿. chloro- ①氯②绿ciclo- 环cis- 顺clo- 氯crypto- 隐cycl- 环cyclo- 环de- 去；脱dec- 十；癸deca- 十；癸dehydro- 去氢；去水demethoxy- 去甲氧（基）demethyl- 去甲（基）deoxy- 去氧des- 去；脱desmethyl- 去甲（基）desoxy- 去氧dex- 右旋dextro- 右旋di- 二diamino- 二氨基diazo- 重氮. dihydro- 二氢；双氢endo- 桥epi- 表；差向epoxy- 环氧erythro- 红；赤estr- 雌ethinyl- 乙炔（基）ethoxyl- 乙氧（基）ethyl- 乙基etio- 初eu- 优fluor- ①氟②荧光fluoro- ①氟②荧光formyl- 甲酰（基）guanyl- 脒基hepta- 七；庚hetero- 杂hexa- 六；己homo- 高(比原化合物多一个-CH2-)hypo- 次io- 碘indo- 碘.iso- 异keto- 酮laevo- 左旋leuco- 白levo- 左旋mercapto- 巯基meso- ①不旋；内消旋②中（间）③中（位）（蒽环的9、10位）meta- ①间（有机系统用名）②偏（无机酸用）methoxy- 甲氧基methyl- 甲基mono- 一；单neo- 新nitro- 硝基nitroso- 亚硝基nona- 九；壬nor- 去甲；降；正nov- 新novo- 新oct- 八；辛octa- 八；辛octo- 八；辛ortho- ①邻（位）②正③原. oxalo- 草oxo- 氧[代]oxy- ①氧②羟基（误称，但常用）para- ①对（位）②副（俗名）penta- 五；戊per- ①高②过phen- 苯pheno- 苯phenoxy- 苯氧（基）phenyl- 苯基phospho- 磷；磷酸phosphor- 磷；磷酸phosphoro- 磷；磷酸phyllo- 叶poly- 多；聚propyl- 丙基proto- 原pseudo- 假；伪；拟ribosyl- 核糖基sec- ①另（指CH3CH2CH(CH3)-型烃基②semi- 半silico- 硅. strept- 链strepto- 链sulf- 硫sulfa- 磺胺（磺胺类药物词头）sulfo- ①硫[代]②磺基sulph- 硫[代]sulpho- ①硫[代]②磺基tert- ①特（指CH3…C(CH3)2-型烃基）②叔tetra- 四thio- 硫trans- 反（式）；转tri- 三undeca- 十一valyl- 缬氨酰（基）vinyl- 乙烯基xantho- 黄色.药名常用词尾-al 醛-aldehyde 醛-amide 酰胺-amidine 脒-amine 胺-ane 烷-ase 酶-ate ①盐②酯-azide 叠氮；-N3-caine 卡因（局部麻醉药词尾）-carbonyl 羰基-carboxamide 甲酰胺-carboxylic acid 羧酸-cidin 杀……菌素-cillin 青霉素；西林（青霉素族抗生素词尾）-cycline 四环素（四环素族抗生素词尾）. -diol ①二醇②二酚-dione 二酮-disulfide 二硫（化物）-ene 烯-enol 烯醇-ester 酯-flavine 黄素-form 仿（俗名词尾）-genin 甙元（旧称配基）-hydrin 醇-ine 碱；素（生物碱词尾）-lactone 内酯-lysin 溶素（俗名词尾）-micin 霉素（抗生素词尾）-mycetin 霉素；菌素（抗生素词尾）-mycin 霉素（抗生素词尾）-nitrile 腈-ol ①醇②酚-olol 心安（心安类药物词尾）-one 酮-ose 糖-oside 糖甙-oxide 氧；氧化物-oyl 酰-quine 奎（俗名尾词）-sporin 孢菌素（抗生素词尾）-sullide 硫（化物）-sulfone 砜-sulfoxide 亚砜-thioic acid 硫代酸-thione 硫酮-thione 硫酮-toxin 毒-triol 三醇-tropin 托品（俗名尾词）-urea 脲-xanthin 黄质-yl 基（一价基）-yne 炔常用分析化学词汇(C to E)玻璃漏斗Glass funnel long stem试管test tube test tube brush test tube holder test tube rack蒸发皿evaporating dish small烧杯beaker锥形瓶Erlenmeyer量筒grad cylinder洗瓶plastic wash bottle勺皿casserole ,smallstoppered flask分液漏斗separalory funnelwater bath/oil bathstrring barmagnetic stirrer冷凝器condenserBallast bottle圆颈烧瓶Round-buttom flask试剂瓶reagent bottles托盘天平platform balance 台秤0.1g 托盘pan 指针刻度表pointer and scale crossbeams and sliding weights 游码分析天平two-pan/single-pan analytical balance 滴定管burette glass bead(basic) nozzle移液管pipette 胖肚elongated glass bulb洗耳球rubber suction bulb玻棒glass rod玻璃活塞stopcock容量瓶pyknowmeter flasks比重瓶(one-mark)volumetric flasks胖肚吸管one-mark pipette刻度吸管graduated pipettes实验仪器清单1、柜子中四、抽屉中：锥形瓶(conical flask) 250ml×4 药匙(medicine spoon)×1 (Erlenmeyer flask) 100 ml×3 滴管(drip tube;dropper)×2烧杯(beaker) 500 ml×1 玻棒(Glass stic)×2250 ml×3 木试管夹(test tube clamp;test tube holder)×1 100 ml×3 胖肚吸管(straws) 25 ml×150 ml×2 10 ml×1容量瓶(volumetric flask) 100 ml×2 乳钵(morta)×150 ml×4 洗耳球(ear wadhing bulb)碘量瓶(iodin numoe flask;iodineflask) 500 ml×3试剂瓶(reagent bottle) （无色）×2（棕色）×2 配洗液：量筒（cylinder）100 ml×1 K2Cr2O72g+5ml水→65mlH2SO4 (graduated cylinder)10ml×1 边加边搅拌(stir)。