ICH安全性领域常用专业术语中英文对照表()

1、ICH安全性领域常用专业术语中英文对照表S9-mixconstituentS9混合液成分Safeguards安全监测Safetypharmacology安全药理学Safetymargin安全范围Salmonellatyphimurium鼠伤寒沙门菌Samplingtime采样时间Satellitegroups卫星组Saturationofabsorption吸收饱和Secondarytesting二期试验Secretioninmilk乳汁分泌Sensitiveperiods敏感期Sensitivity敏感性Sensoryfunctionsandreflexes感觉功能和反射Sexualmatu

2、rity性成熟Shorttermtoxicity短期毒性Shortormedium-termcarcinogenicitystudy短或中期致癌性研究Shorttreatment短期处理Sightingstudies预试验Singledose(acute)toxicity单剂量(急性)毒性Singlestudydesign单一研究设计Site-specifictargeteddelivery定位靶向释放Smallcolony小集落Smallcolonymutant小集落突变体Softagarmethod软琼脂法Solublegenotoxicimpurity可溶性遗传毒性杂质Solventco

3、ntrol溶剂对照Somaticcell体细胞Somaticcelltest体细胞试验Species种属Specificity特异性Speciesspecificity种属特异性Spermanalysis精子分析Spermcount精子计数Spermmaturation精子成熟Spermmorphology精子形态学Spermmotility精子活动度Spermviability精子活力Spermatogenesis精子形成Spindleapparatus纺缍体Stagesofreproduction生殖阶段Standardbatteryoftest标准试验组合Standard3-testba

4、ttery标准三项试验组合Standardbattery标准组合Standardbatterysystem标准组合系统Standardprocedure标准规程Standardprotocol标准试验方案Standardsetofstrains标准菌株组Standardsetoftests标准试验组Standardtestbattery标准试验组合Statisticalevaluation统计学评价Steady-statelevels稳态浓度Step-by-step逐步Stepwiseprocess阶梯式程序Strain品系Structuralchanges结构改变Structuralchro

5、mosomalaberration染色体结构畸变Subgroups亚组Supravitalstaining体外活动染色Surfacerightingreflex平面翻正反射Survival存活率suspension悬浮物Systemicexposure全面接触Targetorgans靶器官Targetcell靶细胞Targethistidinegenes组氨酸目的基因Targettissue靶组织Targettissueexposure靶组织接触Teratogenicresponse致畸胎反应Terminalsacrifice终末期处死Testofcarcinogenicity致癌试验Test

6、approach试验方法Testbatteryapproach试验组合方法Testcompound受试物Testmodel试验模型Teststrategy试验策略Testsystems试验系统Testerstrain试验菌株Therapeutic治疗Therapeuticconfirmatory疗效确定Therapeuticexploratory疗效探索Therapeuticindication治疗适应证Timecourse时程Timingconventions分段计时方法Tissuecross-reactivity组织交叉反应Tissuedistribution组织分布Tissueexpos

7、ure组织接触Tissueuptake组织吸收Tklocustk位点Topconcentration最高浓度Topical局部的Topoisomeraseinhibitor拓朴异构酶抑制剂Totalerythrocyte总红细胞Totallitterloss整窝丢失Toxicitytoreproduction生殖毒性Toxicokinetics毒代动力学（毒物代谢动力学）Transgene转基因Transgenicanimals转基因动物Transgenicplants转基因植物Translocation移位Treatmentregimen实施方案Tubaltransport输卵管运输Tumo

8、rinduction肿瘤诱导Tumorresponse肿瘤反应Tumor-relatedgene肿瘤相关基因Twoorthreephaseapproach分段（二段或三段）研究Twostudydesign分段（两段）研究设计Ovulationrate排卵率Unboundconcentration未结合浓度Unexpectedfinding非预期结果UnscheduledDNAsynthesis（UDS）程序外DNA合成Unstableepoxide不稳定过氧代物Vaginalopening阴道张开Vaginalplug阴栓Wholeblood全血Deadoffspringatbirth出生时死

9、亡的子代Degradation降解Delayofparturition分娩延迟Deletion缺失Descriptivestatistics描述性统计Detectionofbacterialmutagen细菌诱变剂检测Detectionofclastogen染色体断裂剂检测Determinationofmetabolites测定代谢产物Developmentoftheoffspring子代发育Developmentaltoxicity发育毒性Diminutionofthebackgroundlawn背景减少Directgeneticdamage直接遗传损伤Distribution分布DNAad

10、ductDNA加合物DNAdamageDNA损伤DNArepairDNA修复DNAstrandbreaksDNA链断裂Doseescalation剂量递增Dosedependence剂量依赖关系Doselevel剂量水平Dose-limitingtoxicity剂量限制性毒性Dose-ragingstudies剂量范围研究Dose-relativedmutagenicity剂量相关性诱变性Dose-related剂量相关Dose-relativedcytotoxicity剂量相关性细胞毒性Dose-relativedgenotoxicactivity剂量相关性遗传毒性Dose-response

11、curve剂量-反应曲线Dosingroute给药途径Duration周期Durationofpregnancy妊娠周期Eaning断奶Earlierphysicalmalformation早期躯体畸形Earlyembryonicdevelopment早期胚胎发育EarlyembryonicdevelopmenttoimplantationEarlyembryonicdevelopmenttoimplantation着床早期的胚胎发育Electroejaculation电射精Elimination清除Embryofetaldeaths胚胎和胎仔死亡Embryo-fetaldevelopment

12、胚胎-胎仔发育Embryo-fetaltoxicity胚胎-胎仔毒性Embryonicdeath胚胎死亡Embryonicdevelopment胚胎发育Embryonicperiod胚胎期Embryos胚胎Embryotoxicity胚胎毒性Enantiomer对映异构体Endofpregnancy怀孕终止Endocytic内吞噬（胞饮）Endocyticactivity内吞噬活性Endogenousproteins内源性蛋白Endogenouscomponents内源性物质Endogenousgene内源性基因Endonuclease核酸内切酶Emdpmicleasereleasefroml

13、ysosomes溶酶体释放核酸内切酶End-point终点Epididymalspermmaturation附睾精子成熟性Epitope抗原决定部位Errorpronerepair易错性修复Escalation递增Escherichiacolistrain大肠杆菌菌株Escherichiacoli大肠杆菌Evaluationoftestresult试验结果评价Exaggeratedpharmacologicalresponse超常增强的药理作用Excretion排泄（清除）Exposureassessment接触剂量评价Exposureperiod接解期Externalmetabolizing

14、system体外代谢系统F1-animals子一代动物Falsepositiveresult假阳性结果Fecundity多产Feed-back反馈Fertilisation受精Fertility生育力Fertilitystudies生育力研究Fetalabnormalities胎仔异常Fetalandneonatalparameters胎仔和仔鼠的生长发育参数Fetaldevelopmentandgrowth肿仔发育和生长Fetalperiod胎仔期Fetotoxicity胎仔毒性Falsenegativeresult假阴性结果Firstpasstesting一期试验Fluorescencei

15、nsituhybridization(FISH)原位荧光分子杂交Foetuses胎仔Formulation制剂Frameshiftmutation移码突变Frameshitepointmutation移码点突变Free-standing独立Freshdissectiontechnique新鲜切片技术Funtionaldeficits切能缺陷Functionaltest功能试验Functionalindices功能性指标Fusionproteins融合蛋白Gametes配子Genderofanimals动物性别Gender-specificdrug性别专一性药物Geneknockout基因剔除G

16、enetherapy基因治疗Genemutation基因突变Genetic遗传Geneticchange遗传学改变Geneticdamage遗传学损伤Geneticendpoint遗传终点Genetictoxicity遗传毒性Genotoxicactivity遗传毒性作用Genotoxiccarcinogen遗传毒性致癌剂Genotoxiceffect遗传毒性效应Genotoxichazard遗传毒性危害Genotoxicpotential潜在遗传毒性Genotoxicrodentcarcinogen啮齿类动物遗传毒性致癌剂Genotoxicity遗传毒性Genotoxicitytest遗传毒

17、性试验Genotoxicitytestbattery毒性试验组合Genotoxycityevaluation遗传毒性评价Germcellmutagen生殖细胞诱变剂Germlinemutation生殖系统突变GLP临床前研究质量管理规范Grosschromosomaldamage染色体大损伤Grossevaluationofplacenta胎盘的大体评价Growthfactors生长因子Haemotoxylinstaining苏木素染色Half-life半衰期Hematopoieticcells造血细胞Heptachlor七氯化合物Heritable遗传Heritabledefect遗传缺陷H

18、eritabledisease遗传性疾病Heritableeffect遗传效应Highconcentration高浓度Histologicappearanceofreproductiveorgan生殖器官的组织学表现Histopathologicalchang组织病理学改变Homologousproteins同系蛋白Homologousseries同系Hostcell宿主细胞Humansubjects人体Humancarcinogen人类致癌剂HumanlymphoblastoidTH6cell人成淋巴TK6细胞Humanmutagen人类致突变剂Humoralimmunity体液免疫Imma

19、tureerythrocyte未成熟红细胞Immediateandlatenteffect速发和迟发效应Immunogenicity免疫原性Immunopathologicaleffects免疫病理反应immunotoxicity免疫毒性Implantation着床Implantationsites着床部位Invitro体外Invitrotest体外试验Invivo体内Invivotest体风试验Incidenceofpolyploidycell多倍体细胞发生率Incisoreruption门齿萌发Independenttest独立试验Individualfetalbodyweight单个胎仔

20、体重Inducedandspontaneousmodelsofdisease诱发或自发的疾病模型Inducerofmicronuclei微核诱导剂Inhalation吸入InhibitorofDNAmetabolismDNA代谢抑制剂Intactanimals完整动物（整体动物）Internalcontrol内对照Interphasenuclei分裂间期细胞核Intra-andinter-individual个体与个体间Isolatedorgans离休器官Juvenileanimalstudies未成年动物研究Kineticprofile动力学特点Kinetics动力学Lactation授乳、

21、哺乳Largedeletionevent大缺失事件Lateembryoloss后期胚胎丢失Levelofsafety安全水平Libido性欲Lifethreatering危及生命Lipophiliccompound亲脂性化合物Littersize每窝胎仔数目Liveanddealconceptuese活胎和死胎Liveoffspringatbirth出生时存活的子代Localtolerancestudies局部耐受性研究Localtoxicity局部毒性Locu位点Long-termcarcinogenicitystudy长期致癌性研究Lossofthetkgenetk基因缺失Majororg

22、anformation主要器官形成Malefertility雄性生育力Malefertilityassessment雄性生育力评价Mammaliansells哺乳动物细胞Mammalianspecies哺乳类动物Mammaliansellmutationtest哺乳动物细胞致突变试验Marketingapproval上市许可Maternalanimal亲代动物Matingbehavior交配行为Matingperiod交配期Matingratio交配比例Matrices基质Maximumtolerateddose(MTD)最大耐受剂量Mechanismofgenotoxicity遗传毒性机制M

23、echanisticinvestigation机制研究Metabolicactivation代谢活化Metabolicactivationpathway代谢活化途径Metabolicactivationsystem代谢活化系统Metabolism代谢Metabolitesprofile代谢物的概况Metaphase中期Metaphaseanalysis分裂中期相分析Metaphasecell分裂中期相细胞Micronucleus微核Micronucleusformation微核形成Microtitre微滴定Mictotitremethod微滴定法mimicking模拟Mitoticindex有

24、丝分裂指数Molecularcharacterization分子特性Moleculartechnique分子技术Monitor监测Monoclonalantibodies单克隆抗体Non-toxiccompound无毒化合物MouselymphomaL5178Ycell小鼠淋巴瘤L5178Y细胞Mouselymphomatkassay小鼠淋巴溜tk检测Mutagen诱变原Mutageniccarcinogen诱变性致癌剂Mutagenicpotentialofchemical化合物的潜在致突变性Mutantcolony突变体集落Mutation突变Mutationinductionintran

25、sgenes转基因诱导突变Nakedeye肉眼Necropsy(macroscopicexamination)解剖(大体检查)Negativecontrol阴性对照Negativeresult阴性结果Neonateadaptationtoextrauterinelife新生仔宫外生活的适应性Newborn新生仔Newcleated有核Nonrodent非啮齿类Non-clinical非临床Non-genotoxiccarcinogen非遗传毒性致癌剂Non-genotoxicmechanism非遗传毒性机制Non-humanprimate非人灵长类Non-linear非线性No-toxic-e

26、ffectdoselevel无毒性反应剂量水平Nucleatedbonemarrowcell有核骨髓细胞Nucleosideanalogue核苷酸同系物Numberofliveanddeadimplantation宫内活胎和死胎数Numericalchromosomalaberration染色体数目畸变Numericalchromosomechanges染色体数目改变Oestrouscycle动情周期Oligonucleotidegrugs寡核苷酸药物One,twe,threegenerationstudies一、二、三子代研究Organdevelopment器官发育Paraffineembe

27、dding石蜡包埋Parameter参数Parentcompound母体化合物Parenteral非肠道Particulatematerial颗粒物Parturition分娩Pediatricpopulations小儿人群Peproductivecompetence生殖能力Peripheralblooderythrocyte外周血红细胞Pharmacodynamiceffects药效作用Pharmacodynamics药效学（药效动力学）Pharmacokinetic药代动力学Phenylenediamine苯二胺Physicaldevelopment身体发育Physiologicalstre

28、ss生理应激Pilotstudies前期研究Pinnaunfolding耳廓张开Plasmid质粒Plasminogenactivators纤维蛋白溶解酶原激活因子Ploidy整倍体Pointmutation点突变Polychromaticerythrocyte嗜多染色红细胞Polycyclichydrocarbon多环芳烃Polymer聚合物Polyploidycell多倍体细胞Polyploidy多倍体Polyploidyinduction多倍体诱导Poorlysolublecompound难溶化合物Positivecontrol阳性对照Positiveresult阳性结果Postmeio

29、ticstages减数分裂后期Post-approval批准后Postcoitaltimeframe交配后日期Postimplantationdeaths着床后死亡Postnataldeaths出生后死亡Postweaningdevelopmentandgrowth断奶后发育和生长Potential潜在性Potentialimmunogenecity潜在免疫原性Potentialtargetorgansfortoxicity潜在毒性靶器官Pre-andpost-nataldevelopmentstudy围产期的发育研究Pre-andpostweaningsurvivalandgrowth断奶前

30、后的存少和生长Precipitate沉淀期Precision精密度Preclinicalsafetyevaluation临床前安全性评价Predeterminedcriteria预定标准Predictionofcarcinogenicity致癌性预测Pregnant怀孕Pregnantandlactationanimals怀孕与哺乳期动物Preimplantationstagesoftheembryo胚胎着床前期Preimplantationdevelopment着床前发育Preliminarystudies预试验Premating交配前Prematingtreatment交配前给药Pre-s

31、creening预筛选Prevalenceofabnormalities异常情况的普遍程度Preweaning断奶前Primaryactiveentity主要活性实体Priorityselection优先选择Pro-drug前体药物Prolongationofparturition产程延长Proteinbinding蛋白结合率Protocolmodification试验方案修改Quantificationofmutant突变体定量Racemate消旋体Radiolabeledproteins放射性同位素标记蛋白Radiolabelledcompounds放性性同位素标记化合物Range-fin

32、dingtest范围确定试验Rateofpreimplantationdeaths着床关死亡率Rationalstudydesign合理的试验设计Receptorproperties受体性质RecombinantDNAproteinsDNA重组蛋白RecombinantDNAtechnologyDNA重组技术Recombination重组Recombinantplasmafactors重组血浆因子Reductioninthenumberofrevertants回复突变数的减少Relativeplatingefficiency相对接种效率Relativesuspensiongrowth相对悬浮生

33、长率Relativetotalgrowth相对总生长率Relevantanimalspecies相关动物种属Relevantdose相关剂量Relevantfactor相关因素Repeated-dosetoxicitystudies重复剂量毒性研究Reproductivefunction生殖功能Reproductivetoxicity生殖毒性Reproductive/developmentaltoxicity生殖/发育毒性Reversemutation回复突变Reversibility可恢复性（可逆性）Riskassessment危险度评价Rodent啮齿类动物Rodenthematopoie

34、ticcell啮齿类动物造血细胞Routeofadministration给药途径Routinetesting常规试验S9-mixconstituentS9混合液成分Safeguards安全监测Safetypharmacology安全药理学Safetymargin安全范围Salmonellatyphimurium鼠伤寒沙门菌Samplingtime采样时间Satellitegroups卫星组Saturationofabsorption吸收饱和Secondarytesting二期试验Secretioninmilk乳汁分泌Sensitiveperiods敏感期Sensitivity敏感性Senso

35、ryfunctionsandreflexes感觉功能和反射Sexualmaturity性成熟Shorttermtoxicity短期毒性Shortormedium-termcarcinogenicitystudy短或中期致癌性研究Shorttreatment短期处理Sightingstudies预试验Singledose(acute)toxicity单剂量(急性)毒性Singlestudydesign单一研究设计Site-specifictargeteddelivery定位靶向释放Smallcolony小集落Smallcolonymutant小集落突变体Softagarmethod软琼脂法Sol

36、ublegenotoxicimpurity可溶性遗传毒性杂质Solventcontrol溶剂对照Somaticcell体细胞Somaticcelltest体细胞试验Species种属Specificity特异性Speciesspecificity种属特异性Spermanalysis精子分析Spermcount精子计数Spermmaturation精子成熟Spermmorphology精子形态学Spermmotility精子活动度Spermviability精子活力Spermatogenesis精子形成Spindleapparatus纺缍体Stagesofreproduction生殖阶段Standardbatteryoftest标准试验组合Standard3-testbattery标准三项试验组合Standardbattery标准组合Standardbatterysystem标准组合系统Standardprocedure标准规程Standardprotocol标准试验方案Standardsetofstrains标准菌株组Standardsetoftests标准试验组Standardtestbattery标准试验组合Statisticalevaluation统计学评价Steady-statelevels稳态浓度Step-by-step逐步Stepwise