ICH安全性领域专业术语.doc

ICH安全性领域专业术语表英文中文25-fold AUC ratio25倍的AUC比值A single 2 generation study单项包括两代（生殖毒性）的研究Abortions流产Absorption吸收Accuracy准确度Acentric fragment无着丝点片段Acridine orange吖啶橙Active metabolite活性代谢产物Additional test附加试验Adduct加合物Adequate exposure充分暴露ADME吸收、分布、代谢、排泄Administration period给药期Advers effect不良反应Against humanised proteins serum antibodies抗人源蛋白血清抗体Aginal smear阴道涂片Air righting reflex空中翻正反射Alkylating electrophilic center烷化亲电子中心Allele基因突变产生的遗传因子Allergic reactions过敏性反应（变应性反应）Altenative validated test有效替代试验Altered growth生长改变Ammoniun sulphide staining of the uterus子宫硫化胺染色Analogue类似物（同系物）Analogue series of substances同系物Analytical method分析方法Anaphase分裂后期Aneuploidy非整倍体Aneuploidy inducer非整倍体诱导剂Antigenic specificity抗原特异性Apoptosis凋亡Art and ethical standards技术和伦理标准Assessment of genotoxicity遗传毒性评价Attainment of full sexual function达到性成熟AUC曲线下面积Auditory startle reflex惊愕反射（听觉惊跳反射）Autoimmune自身免疫Autoradiographic assessment放射自显影评价Autoradiography放射自显影Bacterial mutagenicity test细菌致突变试验Bacterial reverse mutation test细菌回复突变试验Bacterial strains菌株Bacterial test organisms微生物试验菌Base pairs碱基对Base set of strains基本菌株Base substitution碱基置换Bioanalytical method生物学分析方法Bioavailability生物利用度Biological relevance生物学意义Biotechnological products生物技术产品Biotechnology-derived pharmaceuticals生物技术药物Birth出生Body burden机体负担Bone marrow cell骨髓细胞Bouins fixation包氏液固定Breakage of chromatid染色单体断裂Brealage of chromosome染色体断裂Bridging character桥梁作用C(time)一定剂量、某一时间的浓度Carcinogen致癌物质Carcinogenesis致癌性Carcinogenic hazard致癌性危害Carcinogenicity bioassay致癌性生物检测Carcinogenicity potential of chemical化合物的潜在致癌性Carcinoginicity (oncogenicity)致癌（致瘤）Cardiovascular心血管Case-by-case个例Cell proliferation细胞增殖Cell cultures细胞培养Cell line细胞系Cell membrane lipid细胞膜脂质层Cell replication system细胞复制系统Cell suspension细胞悬液Cell-mediated immunity细胞介导的免疫Cellular therapy细胞治疗Central nervous systems中枢神经系统Cerebral spinal fluid脑脊液Chemical nature化学性质Childbeering potential生育可能性Chinese hamster V79 cell中国仓鼠V79细胞CHL cell中国仓鼠肺细胞CHO cell中国仓鼠卵巢细胞Chromatide染色单体Chromosomal aberration染包体畸变Chromosomal damage染色体损伤Chromosomal integrity染色体完整性Chronic toxicity testing慢性毒性试验Classfical biotransformation studies经典的生物转化试验Clastogen染色体断裂剂Clastogenic致染色体断裂的Cleavage of the balanopreputial gland龟头包皮腺裂开Clinical indication临床适应证Cloning efficiency克隆形成率Closure of the hard palate硬腭闭合Cmax峰浓度Coat growth毛发生长Colony sizing集落大小Comparative trial对比试验Complement binding补体结合Completely novel compound全新化合物Compound bearing structural alerts结构可疑化合物Concentration threshold阈浓度Conception受孕Concomitant toxicokinetics相伴毒代动力学Continuous treatment连续接触Corpora lutea黄体Corpora lutea count黄体数Cross-linking agent交联剂Culture condition培养条件Culture confluency培养克隆率Culture confluenty培养融合Culture medium培养基Cytogenetic change细胞遗传学改变Cytogenetic evaluation细胞遗传学评价Cytokines细胞因子Cytotoxicity细胞毒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-ranging 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早期身体畸形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消除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）Endccytic 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Endonuclease 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Esscherichia 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（消除）Exposure assessment接触剂量评价Exposure period接触期External metabolising 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胎仔发育和生长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 hybridisation (FISH)原位荧光分子杂交Foetuses胎仔Formulation制剂Frameshift mutation移码突变Frameshift point mutation移码点突变Free-standing独立Fresh dissection technique新鲜切片技术Functional deficits功能缺陷Functional test功能试验Funetional 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遗传毒性试验组合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Haematoxylin 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 TK6 cell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体内试验Incidence of polyploid cell多倍体细胞发生率Incisor eruption门齿萌出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离体器官Juvenile animal studies未成年动物研究Kinetic profile动力学特点Kinetics动力学Lactating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 dead 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基因丢失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 cells哺乳动物细胞Mammalian species哺乳类动物Mammalian cell 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 behaviour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Microtitre method微滴定法Mimicking模拟Mitotic index有丝分裂指数Molecular characterisation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小鼠淋巴瘤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-clinieal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, two, 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嗜多染红细胞Polycyclic hydrocarbon多环芳烃Polymer聚合物Polyploid 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断奶前后的存活和生长Precipitate沉淀物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 lactating 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放射性同位素标记化合物Range-finding test范围确定试验Rate of preimplantation deaths着床前死亡率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Recombonant plasma factors重组血浆因子Reduction in the number of revertants回复突变数的减少Relative plating efficieney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Safegards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Specise 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纺锤体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Shandard 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St