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1、Good is good, but better carries it.精益求精，善益求善。医药行业专业英语词汇非常有用-FDA和EDQM术语:CLINICALTRIAL：临床试验ANIMALTRIAL：动物试验ACCELERATEDAPPROVAL：加速批准STANDARDDRUG：标准药物INVESTIGATOR：研究人员；调研人员PREPARINGANDSUBMITTING：起草和申报SUBMISSION：申报；递交BENIFIT（S）：受益RISK（S）：受害DRUGPRODUCT：药物产品DRUGSUBSTANCE：原料药ESTABLISHEDNAME：确定的名称GENERICNAM
2、E：非专利名称PROPRIETARYNAME：专有名称；INN（INTERNATIONALNONPROPRIETARYNAME）：国际非专有名称ADVERSEEFFECT：副作用ADVERSEREACTION：不良反应PROTOCOL：方案ARCHIVALCOPY：存档用副本REVIEWCOPY：审查用副本OFFICIALCOMPENDIUM：法定药典（主要指USP、NF）USP（THEUNITEDSTATESPHARMACOPEIA）：美国药典NF（NATIONALFORMULARY）：（美国）国家处方集OFFICIALPHARMACOPEIAL=COMPENDIAL：药典的；法定的；官方的
3、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）LABELEDAMOUNT：标示量REGULATORYSPECIFICATION：质量管理规格标准（NDA提供）REGULATORYMETHODOLOGY：质量管理方法REGULATORYMETHODSVALIDATION：管理用分析方法的验证COS/CEP欧洲药典符合性认证ICH（InternationalConferenceonHarmonizationofTechnicalRequirementsforRegistrationofPharmaceutical
4、sforHumanUse)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：PharmaceuticalInspectionConvention/PharmaceuticalInspectionCooperationScheme,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
5、（PIC/S）PIC的权威翻译：药品生产检查相互承认公约API(ActivePharmaceuticalIngrediet)原料药又称：活性药物组分AirLock气闸AuthorizedPerson授权人Batch/Lot批次BatchNumber/Lot-Number批号；BatchNumberingSystem批次编码系统；BatchRecords批记录；BulkProduct待包装品；Calibration校正；Cleanarea洁净区；Consignmecnt（Delivery）托销药品。FDA（FOODANDDRUGADMINISTRATION）：（美国）食品药品管理局IND（INV
6、ESTIGATIONALNEWDRUG）：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（NEWDRUGAPPLICATION）：新药申请ANDA（ABBREVIATEDNEWDRUGAPPLICATION）：简化新药申请TREATMENTIND：研究中的新药用于治疗ABBREVIATED（NEW）DRUG：简化申请的新药DMF（DRUGMASTERFILE）：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
7、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（CODEOFFEDERALREGULATION）：（美国）联邦法规PANEL：专家小组BATCHPRODUCTION：批量生产；分批生产BATCHPRODUCTIONRECORDS：生产批号记录POST-ORPRE-MARKETSURVEILLANCE：销售前或销售后监督INFORMEDCONSENT：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）PRESCRIPTIONDRUG：处方药OTCDRUG（OVERTHECOUNTERDRUG）：非处方药GMP文件常见
8、缩写ABPIAssociationoftheBritishPharmaceuticalIndustryADRAdverseDrugReactionAEAdverseEventAIMActiveIngredientManufacturerANDAAbbreviatedNewDrugApplicationANOVAAnalysisofVarianceASM:ActiveSubstanceManufacturerATCAnatomicalTherapeuticChemicalATXAnimalTestExemptionCertificateBANBritishApprovedNameBIRABrit
9、ishInstituteofRegulatoryAffairsBNFBritishNationalFormularyBPBritishPharmacopoeiaCofACertificateofAnalysisCofSCertificateofSuitabilityCENTREFORDRUGEVALUATION(CDE)CentreforPharmaceuticalAdministration(CPA)CMSConcernedMemberStateCMS每个成员国COSCertificateofSuitabilityCPMPCommitteeforProprietaryMedicinalPro
10、ductsCRAClinicalResearchAssociateCRFCaseReportFormCROContractResearchOrganisationCTAClinicalTrialApplicationCTCClinicalTrialCertificateCTDCommonTechnicalDocumentCTXClinicalTrialsExemptionDDDDefinedDailyDoseDGCDailyGlobalComparisonDIADrugInformationAssociationDMFDrugMasterFileDrugRegistrationBranch(D
11、R,ProductEvaluation&RegistrationDivision,CPAEDQM(EuropeanDirectoratefortheQualityofMedicines)欧洲联盟药品质量指导委员会EEA欧洲经济地区EGMAEuropeanGenericsMedicineAssociationELAEstablishedLicenceApplicationEMEAEuropeanMedicinesEvaluationAgencyEMEA（EuropeanAgencyfortheEvaluationofMedicinalProducts）欧洲联盟药品评价机构EPEuropeanPh
12、armacopoeiaEPAREuropeanPublicAssessmentReportsESRAEuropeanSocietyofRegulatoryAffairsEuropeanPharmacopoeiaCommission欧洲药典委员会FDAFDAFoodandDrugAdministrationfinalevaluationreport(FER)freesalecertificates(FSCs)GCPGoodClinicalPracticeGCP药品临床研究管理规范GLPGoodLaboratoryPracticeGLP药品临床前安全性研究质量管理规范GMPGoodManufact
13、uringPracticeGMP药品生产质量管理规范GSP药品销售管理规范HealthSciencesAuthority(HSA)HSAsMedicinesAdvisoryCommittee(MAC)IBInvestigatorsBrochureICHInternationalConferenceforHarmonisationIDMCIndependentData-MonitoringCommitteeIECIndependentEthicsCommitteeINDInvestigationalNewDrugINNInternationalNon-proprietaryNameInterna
14、tionalConferenceonHarmonisation(ICH)IPCInProcessControlIRBInstitutionalReviewBoardLICENCEHOLDERMAMarketingAuthorisationMAAMarketingAuthorisationApplicationMAA上市申请MAHMarketingAuthorisationHolderMAH销售许可持有者MCAMedicinesControlAgencyMHWMinistryofHealthandWelfare(Japan)MRMutualRecognitionMRA美国与欧盟的互认协议MRAs
15、(MutualRecognitionAgreements)互相認證同意MRFGMutualRecognitionFacilitationGroupMRPMutualRecognitionProcedureNASNewActiveSubstanceNCENewChemicalEntityNDANewDrugApplicationnewchemicalentities(NCEs)newdrugapplications(NDAs)NSAIDNonSteroidalAntiInflammatoryDrugNTANoticeToApplicantsOOSOutofSpecificationOTCOver
16、TheCounterPAGBProprietaryAssociationofGreatBritainPhEurEuropeanPharmacopoeiaPILPatientInformationLeafletPLProductLicencePOMPrescriptionOnlyMedicinePRODUCTOWNERPSUPeriodicSafetyUpdatesQAQualityAssuranceQCQualityControlRAJRegulatoryAffairsJournalRMSReferenceMemberStateRMS相互认可另一成员国RSDRelativeStandardDe
17、viationRxPrescriptionOnlySAESeriousAdverseEventSMFSiteMasterFileSOPStandardOperatingProcedureSOP（STANDARDOPERATIONPROCEDURE）标准运作程序SPC/SmPCSummaryofProductCharacteristicssummaryofproductcharacteristics(SPC)TherapeuticGoodsAdministration(TGA)USPUSPharmacopoeiaVMFVeterinaryMasterFileVPCVeterinaryProduc
18、tsCommitteeAAAAdditionandAmendments增补和修订ACAirConditioner空调器ADRAdverseDrugReaction药物不良反应AFDOAssociationofFoodandDrugOfficials食品与药品官员协会（美国）ACCAccept接受AQLAcceptableQualityLevel合格质量标准ADNAAbbreviatedNewDrugApplication简化的新药申请BOMBillofMaterial物料清单BPCBulkpharmaceuticalChemiclls原料药CBERCenterforBiologicsEvalu
19、ationResearch生物制品评价与研究中心CFUColonyFormingUnet菌落形成单位DMFDrugMasterFile药品管理档案CDERCemterforDrugEvaluationamdResearch药物评价与研究中心CICorporateIdentity(Image)企业识别（形象）CIPCleaninginPlace在线清洗CSIConsumerSafetyInsepctor消费者安全调查员CLPCleaningLineProcedure在线清洗程序DALDefectActionLevel缺陷作用水平DEADrugEnforcementAdminestration管制
20、药品管理DSDocumentationSystim文件系统FDAFoodandDrugAdministration食品与药品管理局（美国）GATTGeneralAgreemerntonTariffsandTrade关贸总协会GMPGoodManufacturingPracticeGvp药品生质量管理规范GCPGoodClinicalPractice药品临床实验管理规范GLPGoodLaboratoryPractice实验室管理规范GSPGoodSupplyPractice药品商业质量规范GRPGookRaTAILPractice药品零业质量管理规范GAPGoodAgriculturePract
21、ice药材生产管理规范GVPGookValidationPrctice验证管理规范GUPGookUsePractice药品重用规范HVACHeatingVentilationAirConditioning空调净化系统ISOIntematonalOrganizationforStandardization车际标准化组织MOUMemorandumofUnderstanding谅解备忘录PFPorductionFile生产记录用表格OTCOvertheCounter(Drug)非处方药品PLAProductLicenseApplication产品许可申请QAQualityAssurance质量保证Q
22、CQualityControl质量控制QMPQualityManagementProcedure质量管理程序SDAStateDrugAdministration国家药品监督管理局SMPStandardManagmertProcedure标准管理程序SOPStandardOperatingProcedure标准操作程序TQCTatalQualityControl全面质量管理USAUnetedStatesPharmacopeia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
23、,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tricarboxylicacidcycle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
24、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hecto
25、watt百瓦12.kilo,千kilodalton(KD)千道尔顿kilobase千碱基kiloelectronvolt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d
26、emibariel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,m
27、ult多，复合polyacrylate聚丙烯酸酯polymerase聚合酶multichain多链的multinucleate多核的multicistronicmRNA多顺反子mRNAmulticopy多拷贝1chrom颜色chromophore生色团chromosome染色体chromatography色谱法2melan,melano,nigr黑melanoma黑素瘤melanin黑色素melanophore黑色素细胞3xantho,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let
28、ein黄体素，叶黄素flavinadeninedinucleotide(FAD)黄素腺嘌呤二核苷酸4erythro,rub,rubrm,ruf,红erythrocyte红细胞erythromycin红霉素erythropoitin(EPO)促红细胞生成素5chloro,chlor绿，氯chlorophyll叶绿素chloride氯化物chloramphenicol氯霉素6cyan,cyano蓝，青紫色，氰cyanophyceae蓝藻纲cyanobacteria蓝细菌cyanide氰化物7aur,glid,chrys金色aureomycin金霉素chrysose金藻淀粉chrysanthemum
29、菊花glidstone金沙石glid镀金8leu,leuco,leuk,leuko,blan,alb无色，白色leucine亮氨酸leukaemia=leucosis白血病bleachingpowder漂白粉albomycin白霉素四表示方位和程度的词素1endo,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2ec,ect,exc,extra外，外面，表面ectoblast外胚层ectoparasite外寄生生物extract抽取，浸出3meso中，中间mesosphere中圈，中层mesopla
30、st中胚层质4intra,intro,inter在内，向内intra-allelicinteraction等位基因内相互作用intracellular（细）胞内的interurban城市之间5centri,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6epi,peri上，外，旁epidermalgrowthfactor(EGF):表皮生长因子epibranchial上鳃的perilune近月点7sub,suc,suf,sug下，低，小suborder亚目submucosa粘膜下层subclo
31、ne亚克隆subcellular亚细胞subsection小节，分部8super,supra上，高，超superconductor超导体superfluid超流体superoxide超氧化物supramolecular超分子的9hyper超过，过多hypersensitive过敏的hyperelastic超弹性的hypertension高血压hyperploid超倍体10hypo下，低，次hypoglycaemia低血糖hypotension低血压hypophysis脑下垂体11iso等，相同，同iso-osmotic等渗的isopod等足目动物isotope同位素12oligo，olig少，
32、低，寡，狭oligohaline狭盐性oligogene寡基因oligomer寡聚体oligophagous寡食性oligarchy寡头*13eury多，宽，广eurythermal广温的euryhaline广盐性eurytopicspecies广幅种14ultr超ultra-acoustics超声学ultra-structure超微结构ultroviolet紫外线15infra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1cephal,capit,cran头，
33、头颅2cyte细胞3carn,my,mya,myo,肉，肌肉4haem,haemat,hem,aem,sangul血5soma,corp体，身体6some,plast体，颗粒7hepa,hepat肝heparin肝素hepatopancreas肝胰腺hepatocyte肝细胞hepatoma肝癌8ren,nephr肾adrnal肾上腺的nephridia肾管nephron肾单位9card,cord心cardiotoxin心脏毒素cardiovascularcenter心血管中枢electrocardiogram心电图concord一致，和谐10ophthalm,ocell,ocul眼ophth
34、almology眼科学ophthalmia眼炎ophthalmologist眼科专家11branchi鳃filibranch丝鳃lamellibrnch瓣鳃sencondarybranchium次生鳃12brac,brachi腕，手臂brachiolaria短腕幼虫brachionectin臂粘连蛋白bracelet手镯13dent,odont牙齿dentin牙质odontphora齿舌odontoblast成牙质细胞14plum羽plumatus羽状的plumule绒毛plumage（鸟的）羽毛15foli,foil叶follicle滤泡foiling叶形foliage叶子foliose多叶
35、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-淀粉戊（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be
36、nzyl-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-氯绿chloro-氯绿ciclo-环cis-顺clo-氯crypto-隐cycl-环cyclo-环de-去；脱dec-十；癸deca-十；癸dehydro-去
37、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-氟荧光fluoro-氟荧光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i
38、o-碘indo-碘iso-异keto-酮laevo-左旋leuco-白levo-左旋mercapto-巯基meso-不旋；内消旋中（间）中（位）（蒽环的9、10位）meta-间（有机系统用名）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-邻（位）正原oxalo-草oxo-氧代oxy-氧羟基（误称，但常用）para-对（位）副（俗名）penta-五；戊per-高过phen-苯pheno-苯phenoxy-苯氧（
39、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-另（指CH3CH2CH(CH3)-型烃基semi-半silico-硅strept-链strepto-链sulf-硫sulfa-磺胺（磺胺类药物词头）sulfo-硫代磺基sulph-硫代sulpho-硫代磺基tert-特（指CH3C(CH3)2-型烃基）叔tetra-四thio-硫trans-反（式）；转tri-三undeca-十一valyl-缬氨酰（基）vinyl-乙烯基xant
40、ho-黄色药名常用词尾-al醛-aldehyde醛-amide酰胺-amidine脒-amine胺-ane烷-ase酶-ate盐酯-azide叠氮；-N3-caine卡因（局部麻醉药词尾）-carbonyl羰基-carboxamide甲酰胺-carboxylicacid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二醇二酚-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
41、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醇酚-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-thioicacid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
42、化学词汇(CtoE)玻璃漏斗Glassfunnellongstem试管testtubetesttubebrushtesttubeholdertesttuberack蒸发皿evaporatingdishsmall烧杯beaker锥形瓶Erlenmeyer量筒gradcylinder洗瓶plasticwashbottle勺皿casserole,smallstopperedflask分液漏斗separaloryfunnelwaterbath/oilbathstrringbarmagneticstirrer冷凝器condenserBallastbottle圆颈烧瓶Round-buttomflask试剂
43、瓶reagentbottles托盘天平platformbalance台秤0.1g托盘pan指针刻度表pointerandscalecrossbeamsandslidingweights游码分析天平two-pan/single-pananalyticalbalance滴定管buretteglassbead(basic)nozzle移液管pipette胖肚elongatedglassbulb洗耳球rubbersuctionbulb玻棒glassrod玻璃活塞stopcock容量瓶pyknowmeterflasks比重瓶(one-mark)volumetricflasks胖肚吸管one-markpi
44、pette刻度吸管graduatedpipettes实验仪器清单1、柜子中四、抽屉中：锥形瓶(conicalflask)250ml4药匙(medicinespoon)1(Erlenmeyerflask)100ml3滴管(driptube;dropper)2烧杯(beaker)500ml1玻棒(Glassstic)2250ml3木试管夹(testtubeclamp;testtubeholder)1100ml3胖肚吸管(straws)25ml150ml210ml1容量瓶(volumetricflask)100ml2乳钵(morta)150ml4洗耳球(earwadhingbulb)碘量瓶(iodi
45、nnumoeflask;iodineflask)500ml3试剂瓶(reagentbottle)（无色）2（棕色）2配洗液：量筒（cylinder）100ml1K2Cr2O72g+5ml水65mlH2SO4(graduatedcylinder)10ml1边加边搅拌(stir)。二、台面上仪器：一般仪器的洗涤(wash)铁支架(siderocradle)+蝴蝶架白瓷板(WhitePorcelainBoard)（一）清点仪器(tocount;tomakeaninventory)酸式滴定管(Acidburette)25ml1配洗液(Lotion)碱式滴定管(Alkaliburette)25ml1一般仪器的洗涤三、公用柜中：（二）滴定管(buret;burette)直型冷凝器(rectocondensor)1容量瓶(volumetricflask)漏斗架(funnelstand)2移液管(pipe)水浴锅(waterbathkettle)1温度计(Thermometer;hygrometer;hydroscope)1电炉(elec