ICH安全性領(lǐng)域常用專業(yè)術(shù)語(yǔ)中英文對(duì)照表()

1、ICH安全性領(lǐng)域常用專業(yè)術(shù)語(yǔ)中英文對(duì)照表S9-mixconstituentS9混合液成分Safeguards安全監(jiān)測(cè)Safetypharmacology安全藥理學(xué)Safetymargin安全范圍Salmonellatyphimurium鼠傷寒沙門菌Samplingtime采樣時(shí)間Satellitegroups衛(wèi)星組Saturationofabsorption吸收飽和Secondarytesting二期試驗(yàn)Secretioninmilk乳汁分泌Sensitiveperiods敏感期Sensitivity敏感性Sensoryfunctionsandreflexes感覺(jué)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短期處理Sightingstudies預(yù)試驗(yàn)Singledose(acute)toxicity單劑量(急性)毒性Singlestudydesign單一研究設(shè)計(jì)Site-specifictargeteddelivery定位靶向釋放Smallcolony小集落Smallcolonymutant小集落突變體Softagarmethod軟瓊脂法Solublegenotoxicimpurity可溶性遺傳毒性雜質(zhì)Solventco

3、ntrol溶劑對(duì)照Somaticcell體細(xì)胞Somaticcelltest體細(xì)胞試驗(yàn)Species種屬Specificity特異性Speciesspecificity種屬特異性Spermanalysis精子分析Spermcount精子計(jì)數(shù)Spermmaturation精子成熟Spermmorphology精子形態(tài)學(xué)Spermmotility精子活動(dòng)度Spermviability精子活力Spermatogenesis精子形成Spindleapparatus紡綞體Stagesofreproduction生殖階段Standardbatteryoftest標(biāo)準(zhǔn)試驗(yàn)組合Standard3-testba

4、ttery標(biāo)準(zhǔn)三項(xiàng)試驗(yàn)組合Standardbattery標(biāo)準(zhǔn)組合Standardbatterysystem標(biāo)準(zhǔn)組合系統(tǒng)Standardprocedure標(biāo)準(zhǔn)規(guī)程Standardprotocol標(biāo)準(zhǔn)試驗(yàn)方案Standardsetofstrains標(biāo)準(zhǔn)菌株組Standardsetoftests標(biāo)準(zhǔn)試驗(yàn)組Standardtestbattery標(biāo)準(zhǔn)試驗(yàn)組合Statisticalevaluation統(tǒng)計(jì)學(xué)評(píng)價(jià)Steady-statelevels穩(wěn)態(tài)濃度Step-by-step逐步Stepwiseprocess階梯式程序Strain品系Structuralchanges結(jié)構(gòu)改變Structuralchro

5、mosomalaberration染色體結(jié)構(gòu)畸變Subgroups亞組Supravitalstaining體外活動(dòng)染色Surfacerightingreflex平面翻正反射Survival存活率suspension懸浮物Systemicexposure全面接觸Targetorgans靶器官Targetcell靶細(xì)胞Targethistidinegenes組氨酸目的基因Targettissue靶組織Targettissueexposure靶組織接觸Teratogenicresponse致畸胎反應(yīng)Terminalsacrifice終末期處死Testofcarcinogenicity致癌試驗(yàn)Test

6、approach試驗(yàn)方法Testbatteryapproach試驗(yàn)組合方法Testcompound受試物Testmodel試驗(yàn)?zāi)Ｐ蚑eststrategy試驗(yàn)策略Testsystems試驗(yàn)系統(tǒng)Testerstrain試驗(yàn)菌株Therapeutic治療Therapeuticconfirmatory療效確定Therapeuticexploratory療效探索Therapeuticindication治療適應(yīng)證Timecourse時(shí)程Timingconventions分段計(jì)時(shí)方法Tissuecross-reactivity組織交叉反應(yīng)Tissuedistribution組織分布Tissueexpos

7、ure組織接觸Tissueuptake組織吸收Tklocustk位點(diǎn)Topconcentration最高濃度Topical局部的Topoisomeraseinhibitor拓樸異構(gòu)酶抑制劑Totalerythrocyte總紅細(xì)胞Totallitterloss整窩丟失Toxicitytoreproduction生殖毒性Toxicokinetics毒代動(dòng)力學(xué)（毒物代謝動(dòng)力學(xué)）Transgene轉(zhuǎn)基因Transgenicanimals轉(zhuǎn)基因動(dòng)物Transgenicplants轉(zhuǎn)基因植物Translocation移位Treatmentregimen實(shí)施方案Tubaltransport輸卵管運(yùn)輸Tumo

8、rinduction腫瘤誘導(dǎo)Tumorresponse腫瘤反應(yīng)Tumor-relatedgene腫瘤相關(guān)基因Twoorthreephaseapproach分段（二段或三段）研究Twostudydesign分段（兩段）研究設(shè)計(jì)Ovulationrate排卵率Unboundconcentration未結(jié)合濃度Unexpectedfinding非預(yù)期結(jié)果UnscheduledDNAsynthesis（UDS）程序外DNA合成Unstableepoxide不穩(wěn)定過(guò)氧代物Vaginalopening陰道張開Vaginalplug陰栓Wholeblood全血Deadoffspringatbirth出生時(shí)死

9、亡的子代Degradation降解Delayofparturition分娩延遲Deletion缺失Descriptivestatistics描述性統(tǒng)計(jì)Detectionofbacterialmutagen細(xì)菌誘變劑檢測(cè)Detectionofclastogen染色體斷裂劑檢測(cè)Determinationofmetabolites測(cè)定代謝產(chǎn)物Developmentoftheoffspring子代發(fā)育Developmentaltoxicity發(fā)育毒性Diminutionofthebackgroundlawn背景減少Directgeneticdamage直接遺傳損傷Distribution分布DNAad

10、ductDNA加合物DNAdamageDNA損傷DNArepairDNA修復(fù)DNAstrandbreaksDNA鏈斷裂Doseescalation劑量遞增Dosedependence劑量依賴關(guān)系Doselevel劑量水平Dose-limitingtoxicity劑量限制性毒性Dose-ragingstudies劑量范圍研究Dose-relativedmutagenicity劑量相關(guān)性誘變性Dose-related劑量相關(guān)Dose-relativedcytotoxicity劑量相關(guān)性細(xì)胞毒性Dose-relativedgenotoxicactivity劑量相關(guān)性遺傳毒性Dose-response

11、curve劑量-反應(yīng)曲線Dosingroute給藥途徑Duration周期Durationofpregnancy妊娠周期Eaning斷奶Earlierphysicalmalformation早期軀體畸形Earlyembryonicdevelopment早期胚胎發(fā)育EarlyembryonicdevelopmenttoimplantationEarlyembryonicdevelopmenttoimplantation著床早期的胚胎發(fā)育Electroejaculation電射精Elimination清除Embryofetaldeaths胚胎和胎仔死亡Embryo-fetaldevelopment

12、胚胎-胎仔發(fā)育Embryo-fetaltoxicity胚胎-胎仔毒性Embryonicdeath胚胎死亡Embryonicdevelopment胚胎發(fā)育Embryonicperiod胚胎期Embryos胚胎Embryotoxicity胚胎毒性Enantiomer對(duì)映異構(gòu)體Endofpregnancy懷孕終止Endocytic內(nèi)吞噬（胞飲）Endocyticactivity內(nèi)吞噬活性Endogenousproteins內(nèi)源性蛋白Endogenouscomponents內(nèi)源性物質(zhì)Endogenousgene內(nèi)源性基因Endonuclease核酸內(nèi)切酶Emdpmicleasereleasefroml

13、ysosomes溶酶體釋放核酸內(nèi)切酶End-point終點(diǎn)Epididymalspermmaturation附睪精子成熟性Epitope抗原決定部位Errorpronerepair易錯(cuò)性修復(fù)Escalation遞增Escherichiacolistrain大腸桿菌菌株Escherichiacoli大腸桿菌Evaluationoftestresult試驗(yàn)結(jié)果評(píng)價(jià)Exaggeratedpharmacologicalresponse超常增強(qiáng)的藥理作用Excretion排泄（清除）Exposureassessment接觸劑量評(píng)價(jià)Exposureperiod接解期Externalmetabolizing

14、system體外代謝系統(tǒng)F1-animals子一代動(dòng)物Falsepositiveresult假陽(yáng)性結(jié)果Fecundity多產(chǎn)Feed-back反饋Fertilisation受精Fertility生育力Fertilitystudies生育力研究Fetalabnormalities胎仔異常Fetalandneonatalparameters胎仔和仔鼠的生長(zhǎng)發(fā)育參數(shù)Fetaldevelopmentandgrowth腫仔發(fā)育和生長(zhǎng)Fetalperiod胎仔期Fetotoxicity胎仔毒性Falsenegativeresult假陰性結(jié)果Firstpasstesting一期試驗(yàn)Fluorescencei

15、nsituhybridization(FISH)原位熒光分子雜交Foetuses胎仔Formulation制劑Frameshiftmutation移碼突變Frameshitepointmutation移碼點(diǎn)突變Free-standing獨(dú)立Freshdissectiontechnique新鮮切片技術(shù)Funtionaldeficits切能缺陷Functionaltest功能試驗(yàn)Functionalindices功能性指標(biāo)Fusionproteins融合蛋白Gametes配子Genderofanimals動(dòng)物性別Gender-specificdrug性別專一性藥物Geneknockout基因剔除G

16、enetherapy基因治療Genemutation基因突變Genetic遺傳Geneticchange遺傳學(xué)改變Geneticdamage遺傳學(xué)損傷Geneticendpoint遺傳終點(diǎn)Genetictoxicity遺傳毒性Genotoxicactivity遺傳毒性作用Genotoxiccarcinogen遺傳毒性致癌劑Genotoxiceffect遺傳毒性效應(yīng)Genotoxichazard遺傳毒性危害Genotoxicpotential潛在遺傳毒性Genotoxicrodentcarcinogen嚙齒類動(dòng)物遺傳毒性致癌劑Genotoxicity遺傳毒性Genotoxicitytest遺傳毒

17、性試驗(yàn)Genotoxicitytestbattery毒性試驗(yàn)組合Genotoxycityevaluation遺傳毒性評(píng)價(jià)Germcellmutagen生殖細(xì)胞誘變劑Germlinemutation生殖系統(tǒng)突變GLP臨床前研究質(zhì)量管理規(guī)范Grosschromosomaldamage染色體大損傷Grossevaluationofplacenta胎盤的大體評(píng)價(jià)Growthfactors生長(zhǎng)因子Haemotoxylinstaining蘇木素染色Half-life半衰期Hematopoieticcells造血細(xì)胞Heptachlor七氯化合物Heritable遺傳Heritabledefect遺傳缺陷H

18、eritabledisease遺傳性疾病Heritableeffect遺傳效應(yīng)Highconcentration高濃度Histologicappearanceofreproductiveorgan生殖器官的組織學(xué)表現(xiàn)Histopathologicalchang組織病理學(xué)改變Homologousproteins同系蛋白Homologousseries同系Hostcell宿主細(xì)胞Humansubjects人體Humancarcinogen人類致癌劑HumanlymphoblastoidTH6cell人成淋巴TK6細(xì)胞Humanmutagen人類致突變劑Humoralimmunity體液免疫Imma

19、tureerythrocyte未成熟紅細(xì)胞Immediateandlatenteffect速發(fā)和遲發(fā)效應(yīng)Immunogenicity免疫原性Immunopathologicaleffects免疫病理反應(yīng)immunotoxicity免疫毒性Implantation著床Implantationsites著床部位Invitro體外Invitrotest體外試驗(yàn)Invivo體內(nèi)Invivotest體風(fēng)試驗(yàn)Incidenceofpolyploidycell多倍體細(xì)胞發(fā)生率Incisoreruption門齒萌發(fā)Independenttest獨(dú)立試驗(yàn)Individualfetalbodyweight單個(gè)胎仔

20、體重Inducedandspontaneousmodelsofdisease誘發(fā)或自發(fā)的疾病模型Inducerofmicronuclei微核誘導(dǎo)劑Inhalation吸入InhibitorofDNAmetabolismDNA代謝抑制劑Intactanimals完整動(dòng)物（整體動(dòng)物）Internalcontrol內(nèi)對(duì)照Interphasenuclei分裂間期細(xì)胞核Intra-andinter-individual個(gè)體與個(gè)體間Isolatedorgans離休器官Juvenileanimalstudies未成年動(dòng)物研究Kineticprofile動(dòng)力學(xué)特點(diǎn)Kinetics動(dòng)力學(xué)Lactation授乳、

21、哺乳L(zhǎng)argedeletionevent大缺失事件Lateembryoloss后期胚胎丟失Levelofsafety安全水平Libido性欲Lifethreatering危及生命Lipophiliccompound親脂性化合物L(fēng)ittersize每窩胎仔數(shù)目Liveanddealconceptuese活胎和死胎Liveoffspringatbirth出生時(shí)存活的子代Localtolerancestudies局部耐受性研究Localtoxicity局部毒性Locu位點(diǎn)Long-termcarcinogenicitystudy長(zhǎng)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雄性生育力評(píng)價(jià)Mammaliansells哺乳動(dòng)物細(xì)胞Mammalianspecies哺乳類動(dòng)物Mammaliansellmutationtest哺乳動(dòng)物細(xì)胞致突變?cè)囼?yàn)Marketingapproval上市許可Maternalanimal親代動(dòng)物Matingbehavior交配行為Matingperiod交配期Matingratio交配比例Matrices基質(zhì)Maximumtolerateddose(MTD)最大耐受劑量Mechanismofgenotoxicity遺傳毒性機(jī)制M

23、echanisticinvestigation機(jī)制研究Metabolicactivation代謝活化Metabolicactivationpathway代謝活化途徑Metabolicactivationsystem代謝活化系統(tǒng)Metabolism代謝Metabolitesprofile代謝物的概況Metaphase中期Metaphaseanalysis分裂中期相分析Metaphasecell分裂中期相細(xì)胞Micronucleus微核Micronucleusformation微核形成Microtitre微滴定Mictotitremethod微滴定法mimicking模擬Mitoticindex有

24、絲分裂指數(shù)Molecularcharacterization分子特性Moleculartechnique分子技術(shù)Monitor監(jiān)測(cè)Monoclonalantibodies單克隆抗體Non-toxiccompound無(wú)毒化合物MouselymphomaL5178Ycell小鼠淋巴瘤L5178Y細(xì)胞Mouselymphomatkassay小鼠淋巴溜tk檢測(cè)Mutagen誘變?cè)璏utageniccarcinogen誘變性致癌劑Mutagenicpotentialofchemical化合物的潛在致突變性Mutantcolony突變體集落Mutation突變Mutationinductionintran

25、sgenes轉(zhuǎn)基因誘導(dǎo)突變Nakedeye肉眼Necropsy(macroscopicexamination)解剖(大體檢查)Negativecontrol陰性對(duì)照Negativeresult陰性結(jié)果Neonateadaptationtoextrauterinelife新生仔宮外生活的適應(yīng)性Newborn新生仔Newcleated有核Nonrodent非嚙齒類Non-clinical非臨床Non-genotoxiccarcinogen非遺傳毒性致癌劑Non-genotoxicmechanism非遺傳毒性機(jī)制Non-humanprimate非人靈長(zhǎng)類Non-linear非線性No-toxic-e

26、ffectdoselevel無(wú)毒性反應(yīng)劑量水平Nucleatedbonemarrowcell有核骨髓細(xì)胞Nucleosideanalogue核苷酸同系物Numberofliveanddeadimplantation宮內(nèi)活胎和死胎數(shù)Numericalchromosomalaberration染色體數(shù)目畸變Numericalchromosomechanges染色體數(shù)目改變Oestrouscycle動(dòng)情周期Oligonucleotidegrugs寡核苷酸藥物One,twe,threegenerationstudies一、二、三子代研究Organdevelopment器官發(fā)育Paraffineembe

27、dding石蠟包埋Parameter參數(shù)Parentcompound母體化合物Parenteral非腸道Particulatematerial顆粒物Parturition分娩Pediatricpopulations小兒人群Peproductivecompetence生殖能力Peripheralblooderythrocyte外周血紅細(xì)胞Pharmacodynamiceffects藥效作用Pharmacodynamics藥效學(xué)（藥效動(dòng)力學(xué)）Pharmacokinetic藥代動(dòng)力學(xué)Phenylenediamine苯二胺Physicaldevelopment身體發(fā)育Physiologicalstre

28、ss生理應(yīng)激Pilotstudies前期研究Pinnaunfolding耳廓張開Plasmid質(zhì)粒Plasminogenactivators纖維蛋白溶解酶原激活因子Ploidy整倍體Pointmutation點(diǎn)突變Polychromaticerythrocyte嗜多染色紅細(xì)胞Polycyclichydrocarbon多環(huán)芳烴Polymer聚合物Polyploidycell多倍體細(xì)胞Polyploidy多倍體Polyploidyinduction多倍體誘導(dǎo)Poorlysolublecompound難溶化合物Positivecontrol陽(yáng)性對(duì)照Positiveresult陽(yáng)性結(jié)果Postmeio

29、ticstages減數(shù)分裂后期Post-approval批準(zhǔn)后Postcoitaltimeframe交配后日期Postimplantationdeaths著床后死亡Postnataldeaths出生后死亡Postweaningdevelopmentandgrowth斷奶后發(fā)育和生長(zhǎng)Potential潛在性Potentialimmunogenecity潛在免疫原性Potentialtargetorgansfortoxicity潛在毒性靶器官Pre-andpost-nataldevelopmentstudy圍產(chǎn)期的發(fā)育研究Pre-andpostweaningsurvivalandgrowth斷奶前

30、后的存少和生長(zhǎng)Precipitate沉淀期Precision精密度Preclinicalsafetyevaluation臨床前安全性評(píng)價(jià)Predeterminedcriteria預(yù)定標(biāo)準(zhǔn)Predictionofcarcinogenicity致癌性預(yù)測(cè)Pregnant懷孕Pregnantandlactationanimals懷孕與哺乳期動(dòng)物Preimplantationstagesoftheembryo胚胎著床前期Preimplantationdevelopment著床前發(fā)育Preliminarystudies預(yù)試驗(yàn)Premating交配前Prematingtreatment交配前給藥Pre-s

31、creening預(yù)篩選Prevalenceofabnormalities異常情況的普遍程度Preweaning斷奶前Primaryactiveentity主要活性實(shí)體Priorityselection優(yōu)先選擇Pro-drug前體藥物Prolongationofparturition產(chǎn)程延長(zhǎng)Proteinbinding蛋白結(jié)合率Protocolmodification試驗(yàn)方案修改Quantificationofmutant突變體定量Racemate消旋體Radiolabeledproteins放射性同位素標(biāo)記蛋白R(shí)adiolabelledcompounds放性性同位素標(biāo)記化合物Range-fin

32、dingtest范圍確定試驗(yàn)Rateofpreimplantationdeaths著床關(guān)死亡率Rationalstudydesign合理的試驗(yàn)設(shè)計(jì)Receptorproperties受體性質(zhì)RecombinantDNAproteinsDNA重組蛋白R(shí)ecombinantDNAtechnologyDNA重組技術(shù)Recombination重組Recombinantplasmafactors重組血漿因子Reductioninthenumberofrevertants回復(fù)突變數(shù)的減少Relativeplatingefficiency相對(duì)接種效率Relativesuspensiongrowth相對(duì)懸浮生

33、長(zhǎng)率Relativetotalgrowth相對(duì)總生長(zhǎng)率Relevantanimalspecies相關(guān)動(dòng)物種屬Relevantdose相關(guān)劑量Relevantfactor相關(guān)因素Repeated-dosetoxicitystudies重復(fù)劑量毒性研究Reproductivefunction生殖功能Reproductivetoxicity生殖毒性Reproductive/developmentaltoxicity生殖/發(fā)育毒性Reversemutation回復(fù)突變Reversibility可恢復(fù)性（可逆性）Riskassessment危險(xiǎn)度評(píng)價(jià)Rodent嚙齒類動(dòng)物Rodenthematopoie

34、ticcell嚙齒類動(dòng)物造血細(xì)胞Routeofadministration給藥途徑Routinetesting常規(guī)試驗(yàn)S9-mixconstituentS9混合液成分Safeguards安全監(jiān)測(cè)Safetypharmacology安全藥理學(xué)Safetymargin安全范圍Salmonellatyphimurium鼠傷寒沙門菌Samplingtime采樣時(shí)間Satellitegroups衛(wèi)星組Saturationofabsorption吸收飽和Secondarytesting二期試驗(yàn)Secretioninmilk乳汁分泌Sensitiveperiods敏感期Sensitivity敏感性Senso

35、ryfunctionsandreflexes感覺(jué)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短期處理Sightingstudies預(yù)試驗(yàn)Singledose(acute)toxicity單劑量(急性)毒性Singlestudydesign單一研究設(shè)計(jì)Site-specifictargeteddelivery定位靶向釋放Smallcolony小集落Smallcolonymutant小集落突變體Softagarmethod軟瓊脂法Sol

36、ublegenotoxicimpurity可溶性遺傳毒性雜質(zhì)Solventcontrol溶劑對(duì)照Somaticcell體細(xì)胞Somaticcelltest體細(xì)胞試驗(yàn)Species種屬Specificity特異性Speciesspecificity種屬特異性Spermanalysis精子分析Spermcount精子計(jì)數(shù)Spermmaturation精子成熟Spermmorphology精子形態(tài)學(xué)Spermmotility精子活動(dòng)度Spermviability精子活力Spermatogenesis精子形成Spindleapparatus紡綞體Stagesofreproduction生殖階段Standardbatteryoftest標(biāo)準(zhǔn)試驗(yàn)組合Standard3-testbattery標(biāo)準(zhǔn)三項(xiàng)試驗(yàn)組合Standardbattery標(biāo)準(zhǔn)組合Standardbatterysystem標(biāo)準(zhǔn)組合系統(tǒng)Standardprocedure標(biāo)準(zhǔn)規(guī)程Standardprotocol標(biāo)準(zhǔn)試驗(yàn)方案Standardsetofstrains標(biāo)準(zhǔn)菌株組Standardsetoftests標(biāo)準(zhǔn)試驗(yàn)組Standardtestbattery標(biāo)準(zhǔn)試驗(yàn)組合Statisticalevaluation統(tǒng)計(jì)學(xué)評(píng)價(jià)Steady-statelevels穩(wěn)態(tài)濃度Step-by-step逐步Stepwise