ICH 安全性领域常用专业术语中英文对照表().doc

ICH 安全性领域常用专业术语中英文对照表S9-mix constituentS9混合液成分Safeguards安全监测Safety pharmacology安全药理学Safety margin安全范围Salmonella typhimurium鼠伤寒沙门菌Sampling time采样时间Satellite groups卫星组Saturation of absorption吸收饱和Secondary testing二期试验Secretion in milk乳汁分泌Sensitive periods敏感期Sensitivity敏感性Sensory functions and reflexes感觉功能和反射Sexual maturity性成熟Short term toxicity短期毒性Short or medium-term carcinogenicity study短或中期致癌性研究Short treatment短期处理Sighting studies预试验Single dose(acute)toxicity单剂量(急性)毒性Single study design单一研究设计Site-specific targeted delivery定位靶向释放 Small colony小集落Small colony mutant小集落突变体Soft agar method软琼脂法Soluble genotoxic impurity可溶性遗传毒性杂质Solvent control溶剂对照 Somatic cell体细胞Somatic cell test体细胞试验Species种属Specificity特异性Species specificity种属特异性Sperm analysis精子分析Sperm count精子计数Sperm maturation精子成熟Sperm morphology精子形态学Sperm motility精子活动度Sperm viability精子活力Spermatogenesis精子形成Spindle apparatus纺缍体Stages of reproduction生殖阶段Standard battery of test标准试验组合Standard 3-test battery标准三项试验组合Standard battery 标准组合Standard battery system标准组合系统Standard procedure标准规程Standard protocol标准试验方案Standard set of strains标准菌株组Standard set of tests标准试验组Standard test battery标准试验组合Statistical evaluation统计学评价Steady-state levels稳态浓度Step-by-step逐步Stepwise process阶梯式程序Strain品系Structural changes结构改变Structural chromosomal aberration染色体结构畸变Subgroups亚组Supravital staining体外活动染色Surface righting reflex平面翻正反射Survival存活率suspension悬浮物Systemic exposure全面接触 Target organs靶器官Target cell靶细胞Target histidine genes组氨酸目的基因Target tissue靶组织Target tissue exposure靶组织接触Teratogenic response致畸胎反应Terminal sacrifice终末期处死Test of carcinogenicity致癌试验Test approach试验方法Test battery approach试验组合方法Test compound 受试物Test model试验模型Test strategy试验策略Test systems试验系统Tester strain试验菌株Therapeutic治疗Therapeutic confirmatory疗效确定Therapeutic exploratory疗效探索Therapeutic indication治疗适应证Time course时程Timing conventions分段计时方法Tissue cross-reactivity组织交叉反应Tissue distribution组织分布Tissue exposure组织接触Tissue uptake组织吸收Tk locustk位点Top concentration最高浓度Topical局部的Topoisomerase inhibitor拓朴异构酶抑制剂Total erythrocyte总红细胞Total litter loss整窝丢失Toxicity to reproduction生殖毒性Toxicokinetics毒代动力学(毒物代谢动力学)Transgene转基因Transgenic animals转基因动物Transgenic plants转基因植物Translocation移位Treatment regimen实施方案Tubal transport输卵管运输Tumor induction肿瘤诱导Tumor response肿瘤反应Tumor-related gene肿瘤相关基因Two or three phase approach分段(二段或三段)研究Two study design分段(两段)研究设计Ovulation rate排卵率Unbound concentration未结合浓度Unexpected finding非预期结果Unscheduled DNA synthesis(UDS)程序外DNA合成Unstable epoxide不稳定过氧代物Vaginal opening阴道张开Vaginal plug阴栓Whole blood全血Dead offspring at birth出生时死亡的子代Degradation降解Delay of parturition分娩延迟Deletion缺失Descriptive statistics描述性统计Detection of bacterial mutagen细菌诱变剂检测Detection of clastogen染色体断裂剂检测Determination of metabolites测定代谢产物Development of the offspring子代发育Developmental toxicity发育毒性Diminution of the background lawn背景减少Direct genetic damage直接遗传损伤Distribution分布DNA adductDNA加合物DNA damageDNA损伤DNA repairDNA修复DNA strand breaksDNA链断裂Dose escalation剂量递增Dose dependence剂量依赖关系Dose level剂量水平Dose-limiting toxicity剂量限制性毒性Dose-raging studies剂量范围研究Dose-relatived mutagenicity剂量相关性诱变性Dose-related剂量相关Dose-relatived cytotoxicity剂量相关性细胞毒性Dose-relatived genotoxic activity剂量相关性遗传毒性Dose-response curve剂量-反应曲线Dosing route给药途径Duration周期Duration of pregnancy妊娠周期Eaning断奶Earlier physical malformation早期躯体畸形Early embryonic development早期胚胎发育Early embryonic development to implantation着床早期的胚胎发育Electro ejaculation电射精Elimination清除Embryofetal deaths胚胎和胎仔死亡Embryo-fetal development胚胎-胎仔发育Embryo-fetal toxicity胚胎-胎仔毒性Embryonic death胚胎死亡Embryonic development胚胎发育Embryonic period胚胎期Embryos胚胎Embryotoxicity胚胎毒性Enantiomer对映异构体End of pregnancy怀孕终止Endocytic内吞噬(胞饮)Endocytic activity内吞噬活性Endogenous proteins内源性蛋白 Endogenous components内源性物质Endogenous gene内源性基因Endonuclease核酸内切酶Emdpmiclease release from lysosomes溶酶体释放核酸内切酶End-point终点Epididymal sperm maturation附睾精子成熟性Epitope抗原决定部位Error prone repair易错性修复Escalation递增Escherichia coli strain大肠杆菌菌株Escherichia coli大肠杆菌Evaluation of test result试验结果评价Exaggerated pharmacological response超常增强的药理作用Excretion排泄(清除)Exposure assessment接触剂量评价Exposure period接解期External metabolizing system体外代谢系统F1-animals子一代动物False positive result假阳性结果Fecundity多产Feed-back反馈Fertilisation受精Fertility生育力Fertility studies生育力研究Fetal abnormalities胎仔异常Fetal and neonatal parameters胎仔和仔鼠的生长发育参数Fetal development and growth肿仔发育和生长Fetal period胎仔期Fetotoxicity胎仔毒性False negative result假阴性结果First pass testing一期试验Fluorescence in situ hybridization(FISH)原位荧光分子杂交Foetuses胎仔Formulation制剂Frameshift mutation移码突变Frameshite point mutation移码点突变Free-standing独立Fresh dissection technique新鲜切片技术Funtional deficits切能缺陷Functional test功能试验Functional indices功能性指标Fusion proteins融合蛋白Gametes配子Gender of animals动物性别Gender-specific drug性别专一性药物Gene knockout基因剔除Gene therapy基因治疗Gene mutation基因突变Genetic遗传Genetic change遗传学改变Genetic damage遗传学损伤Genetic endpoint遗传终点Genetic toxicity遗传毒性Genotoxic activity遗传毒性作用Genotoxic carcinogen遗传毒性致癌剂Genotoxic effect遗传毒性效应Genotoxic hazard遗传毒性危害Genotoxic potential潜在遗传毒性Genotoxic rodent carcinogen啮齿类动物遗传毒性致癌剂Genotoxicity遗传毒性Genotoxicity test遗传毒性试验Genotoxicity test battery毒性试验组合Genotoxycity evaluation遗传毒性评价Germ cell mutagen生殖细胞诱变剂Germ line mutation生殖系统突变GLP临床前研究质量管理规范Gross chromosomal damage染色体大损伤Gross evaluation of placenta胎盘的大体评价Growth factors生长因子Haemotoxylin staining苏木素染色Half-life半衰期Hematopoietic cells造血细胞Heptachlor七氯化合物Heritable遗传Heritable defect遗传缺陷Heritable disease遗传性疾病Heritable effect遗传效应High concentration高浓度Histologic appearance of reproductive organ生殖器官的组织学表现Histopathological chang组织病理学改变Homologous proteins同系蛋白Homologous series同系Host cell宿主细胞Human subjects人体Human carcinogen 人类致癌剂Human lymphoblastoid TH6cell人成淋巴TK6细胞Human mutagen人类致突变剂 Humoral immunity体液免疫Immature erythrocyte未成熟红细胞Immediate and latent effect速发和迟发效应Immunogenicity免疫原性Immunopathological effects免疫病理反应immunotoxicity免疫毒性Implantation着床Implantation sites着床部位In vitro体外In vitro test体外试验In vivo 体内In vivo test体风试验Incidence of polyploidy cell多倍体细胞发生率Incisor eruption门齿萌发Independent test独立试验Individual fetal body weight单个胎仔体重Induced and spontaneous models of disease诱发或自发的疾病模型Inducer of micronuclei微核诱导剂Inhalation吸入Inhibitor of DNA metabolismDNA代谢抑制剂 Intact animals完整动物(整体动物)Internal control内对照Interphase nuclei分裂间期细胞核Intra-and inter-individual个体与个体间Isolated organs离休器官Juvenile animal studies未成年动物研究Kinetic profile动力学特点Kinetics动力学Lactation授乳、哺乳Large deletion event大缺失事件Late embryo loss后期胚胎丢失Level of safety安全水平Libido性欲Life threatering危及生命Lipophilic compound亲脂性化合物Litter size每窝胎仔数目Live and deal conceptuese活胎和死胎Live offspring at birth出生时存活的子代Local tolerance studies局部耐受性研究Local toxicity局部毒性Locu位点Long-term carcinogenicity study长期致癌性研究Loss of the tk genetk基因缺失Major organ formation主要器官形成Male fertility雄性生育力Male fertility assessment雄性生育力评价Mammalian sells哺乳动物细胞Mammalian species哺乳类动物Mammalian sell mutation test哺乳动物细胞致突变试验Marketing approval上市许可Maternal animal亲代动物Mating behavior交配行为Mating period交配期Mating ratio交配比例Matrices基质Maximum tolerated dose(MTD)最大耐受剂量Mechanism of genotoxicity遗传毒性机制Mechanistic investigation机制研究Metabolic activation代谢活化Metabolic activation pathway代谢活化途径Metabolic activation system代谢活化系统Metabolism代谢 Metabolites profile代谢物的概况Metaphase中期Metaphase analysis分裂中期相分析Metaphase cell分裂中期相细胞Micronucleus微核Micronucleus formation微核形成Microtitre微滴定Mictotitre method微滴定法mimicking模拟Mitotic index有丝分裂指数Molecular characterization分子特性Molecular technique分子技术Monitor监测Monoclonal antibodies单克隆抗体Non-toxic compound无毒化合物Mouse lymphoma L5178Y cell小鼠淋巴瘤L5178Y细胞Mouse lymphoma tk assay小鼠淋巴溜tk检测Mutagen诱变原Mutagenic carcinogen诱变性致癌剂Mutagenic potential of chemical化合物的潜在致突变性Mutant colony突变体集落Mutation突变Mutation induction in transgenes转基因诱导突变Naked eye肉眼Necropsy(macroscopic examination)解剖(大体检查)Negative control阴性对照Negative result阴性结果Neonate adaptation to extrauterine life新生仔宫外生活的适应性Newborn 新生仔Newcleated有核 Non rodent非啮齿类Non-clinical非临床Non-genotoxic carcinogen非遗传毒性致癌剂Non-genotoxic mechanism非遗传毒性机制Non-human primate非人灵长类Non-linear非线性No-toxic-effect dose level无毒性反应剂量水平Nucleated bone marrow cell有核骨髓细胞Nucleoside analogue核苷酸同系物Number of live and dead implantation宫内活胎和死胎数Numerical chromosomal aberration染色体数目畸变Numerical chromosome changes染色体数目改变Oestrous cycle动情周期Oligonucleotide grugs寡核苷酸药物One ,twe,three generation studies一、二、三子代研究Organ development器官发育Paraffine embedding石蜡包埋Parameter参数Parent compound母体化合物Parenteral非肠道Particulate material颗粒物Parturition分娩Pediatric populations小儿人群Peproductive competence生殖能力Peripheral blood erythrocyte外周血红细胞Pharmacodynamic effects药效作用Pharmacodynamics药效学(药效动力学)Pharmacokinetic药代动力学Phenylene diamine苯二胺Physical development身体发育Physiological stress生理应激Pilot studies前期研究Pinna unfolding耳廓张开Plasmid质粒Plasminogen activators纤维蛋白溶解酶原激活因子Ploidy整倍体Point mutation点突变Polychromatic erythrocyte嗜多染色红细胞Polycyclic hydrocarbon多环芳烃Polymer聚合物Polyploidy cell多倍体细胞Polyploidy多倍体Polyploidy induction多倍体诱导Poorly soluble compound难溶化合物Positive control阳性对照Positive result阳性结果Post meiotic stages减数分裂后期Post-approval批准后Postcoital time frame交配后日期Postimplantation deaths着床后死亡Postnatal deaths出生后死亡Postweaning development and growth断奶后发育和生长Potential潜在性Potential immunogenecity潜在免疫原性Potential target organs for toxicity潜在毒性靶器官Pre-and post-natal development study围产期的发育研究Pre-and postweaning survival and growth断奶前后的存少和生长Precipitate沉淀期Precision精密度Preclinical safety evaluation临床前安全性评价Predetermined criteria预定标准Prediction of carcinogenicity致癌性预测Pregnant怀孕Pregnant and lactation animals怀孕与哺乳期动物Preimplantation stages of the embryo胚胎着床前期Preimplantation development着床前发育Preliminary studies预试验Premating交配前Premating treatment交配前给药Pre-screening预筛选Prevalence of abnormalities异常情况的普遍程度Preweaning断奶前Primary active entity主要活性实体Priority selection优先选择Pro-drug前体药物Prolongation of parturition产程延长Protein binding蛋白结合率Protocol modification试验方案修改Quantification of mutant突变体定量Racemate消旋体Radiolabeled proteins放射性同位素标记蛋白Radiolabelled compounds放性性同位素标记化合物Range-finding test范围确定试验Rate of preimplantation deaths着床关死亡率Rational study design合理的试验设计Receptor properties受体性质Recombinant DNA proteinsDNA重组蛋白Recombinant DNA technologyDNA重组技术Recombination重组Recombinant plasma factors重组血浆因子 Reduction in the number of revertants回复突变数的减少Relative plating efficiency相对接种效率Relative suspension growth相对悬浮生长率Relative total growth相对总生长率Relevant animal species相关动物种属Relevant dose相关剂量Relevant factor相关因素Repeated-dose toxicity studies重复剂量毒性研究Reproductive function生殖功能Reproductive toxicity生殖毒性Reproductive/developmental toxicity生殖/发育毒性Reverse mutation回复突变Reversibility可恢复性(可逆性)Risk assessment危险度评价Rodent啮齿类动物Rodent hematopoietic cell啮齿类动物造血细胞Route of administration给药途径Routine testing常规试验S9-mix constituentS9混合液成分Safeguards安全监测Safety pharmacology安全药理学Safety margin安全范围Salmonella typhimurium鼠伤寒沙门菌Sampling time采样时间Satellite groups卫星组Saturation of absorption吸收饱和Secondary testing二期试验Secretion in milk乳汁分泌Sensitive periods敏感期Sensitivity敏感性Sensory functions and reflexes感觉功能和反射Sexual maturity性成熟Short term toxicity短期毒性Short or medium-term carcinogenicity study短或中期致癌性研究Short treatment短期处理Sighting studies预试验Single dose(acute)toxicity单剂量(急性)毒性Single study design单一研究设计Site-specific targeted delivery定位靶向释放 Small colony小集落Small colony mutant小集落突变体Soft agar method软琼脂法Soluble genotoxic impurity可溶性遗传毒性杂质Solvent control溶剂对照 Somatic cell体细胞Somatic cell test体细胞试验Species种属Specificity特异性Species specificity种属特异性Sperm analysis精子分析Sperm count精子计数Sperm maturation精子成熟Sperm morphology精子形态学Sperm motility精子活动度Sperm viability精子活力Spermatogenesis精子形成Spindle apparatus纺缍体Stages of reproduction生殖阶段Standard battery of test标准试验组合Standard 3-test battery标准三项试验组合Standard battery 标准组合Standard battery system标准组合系统Standard procedure标准规程Standard protocol标准试验方案Standard set of strains标准菌株组Standard set of tests标准试验组Standard test battery标准试验组合Statistical evaluation统计学评价Steady-state levels稳态浓度Step-by-step逐步Stepwise