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1、ICHICH领领域域专专业业术术语语表表（质质量量、安安全全性性）序序号号英英文文中中文文1relevant viruses and model viruses“相关”病毒和“模型”病毒225-fold AUC radio25倍的AUC比值3a single 2 generation study单项包括两代（生殖毒性）的研究4abbreviated or abridged application简略申请5abnormal karyology异常核形6abortions流产7absorbed moisture吸附水8absorption吸收9acceptable daily intake可接受的
2、日摄入量10acceptable test加速试验11acceptance criteia认可标准12accuracy准确性13accuracy准确度14acelerated/stress stability studies加速/强力破坏稳定性研究15acentric fragment无着丝点片段16acetylation 乙酰化作用17achiral assay非手性测定18achlorhydric eldderly老年性胃酸缺乏症19acridine orange吖啶橙20action limits内控限值21active components/compound/moiety活性成分22a
3、ctive ingredient活性组分23active metabolite活性代谢产物24adaption to specific culture conditions特定培养条件的适应25additional test 附加实验26additions添加剂27adduct加合物28adequate exposure充分暴露29adjuvant 佐剂30ADME吸收、分布、代谢、排泄31administration period给药期32adventitious agents外源性因子33adventitious contaminants外来污染物34adventitious viral
4、or mycoplasma contamination外源性病毒或支原体污染35adventitious viruses外源病毒36advers effect不良反应37adverse reaction不良反应38aerobic microorganisms需氧微生物39affinity亲和力40affinity chromatography亲和层析41affinity column亲和柱42against humanised proteins serum antibodies抗人源蛋白血清抗体43agar and broth琼脂和肉汤44aggregates 聚合体45aggregation
5、聚集46aginal smear阴道涂片47air ighting reflex空中翻正反射48alkylating electrophilic center烷化亲电子中心49allele基因突变产生的遗传因子50allergenic/allergic extracts过敏原抽提物51allergic reactions过敏性反应（变应性反应）52altenative validated test有效替代试验53altered conjugated forms改变的结合物形式54altered growth 生长改变55ambient condition自然条件56amino acid com
6、position氨基酸组成57amino acid sequence氨基酸顺序58amino acids氨基酸59amino sugars氨基糖60amino-terminal amino acids氨基端氨基酸61ammonia production Rates产氨率62ammoniun sulphide staining of the uterus子宫硫化胺染色63analogue类似物（同系物）64analogue series of substances同系物65analyte 被测物66analytical method 分析方法67analytical procedure分析方法6
7、8anaphase分裂后期69aneuploidy非整倍体70aneuploidy inducer非整倍体诱导剂71animal cell lines动物细胞系72animal tissues or organs动物组织或器官73antennary profile 触角形状74antibiotic resistance genes抗生素耐药基因75antibiotics抗生素76antibody抗体77antibody production tests抗体产生试验78antigenic specificity抗原特异性79antisera抗血清80apoptosis凋亡81applicant申
8、报者82art and ethical standards技术和伦理标准83ascites腹水84assay含量测定85assay procedure定量方法86assessment of genotoxicity遗传毒性评价87attainment of full sexual function达到性成熟88AUC曲线下面积89auditory startle relex惊愕反射（听觉惊跳反射）90autoimmune自身免疫91autoradiographic assessment放射自显影评价92autoradiography放射自显影93avian鸟类94avidity亲和性95bac
9、kground 背景96bacteria细菌97bacterial mutagenicity test细菌致变突试验98bacterial reverse mutation test细菌回复突变试验99bacterial strains菌株100bacterial test organisms微生物试验菌101base pairs碱基对102base set of strains基本菌株103base substitution碱基置换104batches批次105batch-to-batch逐批106between-assay variation试验间变异107binary fission双数
10、分裂108binding assays结合试验109bioanalytical method生物学分析方法110bioavaiability生物利用度111bioburden生长量/生物负荷112biochemical methods生化方法113bioequivalency生物等效性114biohazard enformation生物有害信息115biological activity生物活性116biological products生物制品117biological relevance生物学意义118bioreactor生物反应器119biotechnological products生
11、物技术产品120biotechnological/biological products生物技术/生物制品121biotechnology-derived pharmaceuticals生物技术药物122biphasic curve双相曲线123birth出生124blood plasma factors血浆因子125body burden机体负担126body fluids体液127bone marrow cell骨髓细胞128bouins fixation包氏液固定129bovine牛130bovine spongiform encephalopathy(BSE)疯牛病131bracket
12、ing括号法132breakage of chromatid染色单体断裂133breakage of chromosome染色体断裂134breeding conditions饲养条件135bridging character桥梁作用136by-products副产物137C(time)一定剂量、某一时间的浓度138calibrate标化139canine犬140cap liner瓶帽内垫141capillary electrophoresis毛细管电泳142carbohydrate碳水化合物143carboxy-terminal amino acids羧基端氨基酸144carcinogen致
13、癌物质145carcinogenesis致癌性146carcinogenic hazard致癌性危害147carcinogenicity bioassay致癌性生物检测148carcinogenicity potential of chemical化合物的潜在致癌性149carcinoginicity(oncogenicity)致癌（致瘤）150cardiovascular心血管151carrier载体/担体152case-by-case个例153catalysts催化剂154cell bank 细胞库155cell bank system细胞库系统156cell banking proced
14、ures细胞建库过程157cell banking system细胞库系统158cell culture-derived impurities来源于细胞培养基的杂质159cell cultures 细胞培养物160cell cultures 细胞培养161cell expansion细胞扩增162cell fusion细胞融合163cell line细胞系164cell lines 细胞系165cell membrane lipid细胞膜脂质层166cell metabolites细胞代谢物167cell pooling细胞混合168cell proliferation细胞增植169cell
15、replication system细胞复制系统170cell substrate-derived impurities 来源于细胞基质的杂质171cell substrates细胞基质172cell suspension细胞悬液173cell viability细胞活力174cell-derived biological products细胞来源的生物制品175cell-mediated immunity细胞介导的免疫176cellular blood components血细胞成分177cellular therapy细胞治疗178cemadsorbing viruses红细胞吸附病毒17
16、9central nervous systems中枢神经系统180cerbral spinal fluid脑脊液181characterization and testing of cell banks细胞库鉴定及检测182charcoal活性炭183charge电荷184chemical actionmertric system化学光化线强度系统185chemical nature化学性质186chemical reactivity 化学反应性187chemical syntheses化学合成188chemically inert化学惰性189chewable tablets咀嚼片190ch
17、ildbeering potential生育可能性191chinese hamster V79 cell中国仓鼠V79细胞192chiral impurities手性杂质193CHL cell中国仓鼠肺细胞194CHO cell中国仓鼠卵巢细胞195chromatide染色单体196chromatograms色谱图197chromatographic behavior色谱行为198chromatographic procedures色谱方法199chromatography columns色谱分离柱200chromosomal aberration染色体畸变201chromosomal dam
18、age染色体损伤202chromosomal integrity染色体完整性203chronic toxicity testing 慢性毒性试验204circular dichroism圆二色性205classfical biotransformation studies经典的生物转化试验206clastogen染色体断裂剂207clastogenic致染色体断裂的208clearance studies清除研究209cleavage of the balanopreputial gland 龟头包皮腺裂开210climatic zones气候带211clinical indication临床
19、适应证212clinical research临床研究213clinical trial application 临床试验申请214clisure闭塞物215cloning 克隆216cloning efficiency克隆形成率217closure of hard palate硬腭闭合218Cmax峰浓度219coat growth毛发生长220code number编号221coding sequence编码序列222coefficient of variance变异系数223collaborative studies协作实验研究224colony isolation菌落分离225colo
20、ny sizing集落大小226colony-stimulating factors集落刺激因子227combination product复方制剂228comparative trial对比试验229complement binding补体结合230completely novel compound全新化合物231components成分232compound bearing stuctural alerts结构可疑化合物233concentration threshold阈浓度234conception受孕235concomitant toxicokinetics相伴毒代动力学236con
21、fidence interval置信区间237confidence limits可信限238confirmatory studies确认研究239conformance to specifcations符合规范240conformation构型241conjugated product连接产物242conjugation连接243consistency一致性244container容器245container/closure容器/闭塞物246container/closure integrity testing 容器/密封完整性试验247contaminants污染物248contaminat
22、ed cell substrate污染的细胞基质249content uniformity含量均匀度250continuous treatment 连续接触251control methodology控制方法学252controlled released product控释制剂253conventional live virus vaccines传统的活病毒疫苗254conventional vaccines传统疫苗255cool white fluorescent冷白荧光灯256corpora lutea黄体257corpora lutea count黄体数258correction fac
23、tor校正因子259correlation coefficient相关系数260covalent or noncovalent共价或非共价261creams霜剂262cross-contamination交叉污染263cross-linking agent交联剂264cross-reactivity交叉反应265cryopreservation冷冻保存266cryoprotectants防冻剂267crystals晶体268culture components 培养基成分269culture condiction培养条件270culture confluency培养克隆率271culture
24、confluenty培养融合272culture media/medium培养基273culture medium培养基274cyanogen bromide溴化氰275cytogenetic细胞遗传学的276cytogenetic change细胞遗传学改变277cytogenetic evaluation细胞遗传学评价278cytokines细胞因子279cytopathic细胞病的280cytoplasmic A-and R-type particles细胞浆a型和r型颗粒281cytotoxicity细胞毒282dark control暗度控制283dead offspring at
25、birth 出生时死亡的子代284deamidation去氨基285deaminated去酰胺化的286deamination脱氨基287decision flow chart/tree判断图288definable and measurable biological activity明确和可测定的生物学活性289degradant降解产物290degradation降解291degradation pathway降解途径292degradation product降解产物293degradation profile降解概况294degree of aggregation 凝集度295degr
26、ee of scatter离散程度296delay of parturition分娩延迟297delayed-release延迟释放298deleterious有害的299deletion缺失300delivery systems给药体系301derivatives衍生物302description 性状303descriptive statistics描述性统计304detection limit检测限度305detection of bacterial mutagen细菌诱变剂检测306detection of clastogen染色体断裂剂检测307determination of me
27、tabolites测定代谢产物308development of the offspring 子代发育309developmental toxicity发育毒性310dilivery systems释放系统311dilution ratio释放倍数312dimers二聚体313diminution of the background lawn背景减少314diode array二极管阵列315diploid cells二倍体细胞316direct genetic damage 直接遗传损伤317dissociation解离318dissolution testing溶出试验319dissolu
28、tion time溶出时间320distribution分布321DNA adductDNA加合物322DNA damageDNA损伤323DNA repairDNA修复324DNA strand breaksDNA链断裂325dosage form剂型326dose dependence剂量依赖关系327dose escalation剂量递增328dose level剂量水平329dose-liming toxicity剂量限制性毒性330dose-ranging studies剂量范围研究331dose-related剂量相关332dose-relatived cytotoxicity剂量
29、相关性细胞毒性333dose-relatived genotoxic activity剂量相关性遗传毒性334dose-relatived mutagenicity剂量相关性诱变性335dose-response curve剂量反应曲线336dosing route给药途径337downstream purification下游纯化338drug product制剂339drug product components制剂组方340drug substances原料药341duration周期342duration of pregnancy妊娠周期343eaning断奶344earlier ph
30、ysical malformation早期身体畸形345early embryonic development早期胚胎发育346early embryonic development to implantation着床早期的胚胎发育347ectromelia virus脱脚病病毒348elastomeric closures橡皮塞349electro ejaculation电射精350electron microscopy(EM)电镜351electrophoresis电泳352electrophoretic pattern电泳图谱353elimination消除354elution prof
31、ile洗脱方案355embryofetal deaths胚胎和胎仔死亡356embryo-fetal development 胚胎胎仔发育357embryo-fetal toxicity胚胎胎仔毒性358embryonated eggs鸡胚359embryonic death胚胎死亡360embryonic development胚胎发育361embryonic period胚胎期362embryos胚胎363embryotoxicity胚胎毒性364enantiomer对映体365enantiomer对映异构体366enantiomeric镜像异构体367enantioselective对映
32、体选择性368encephalomyocarditis virus(EMC)脑心肌炎病毒369end of pregnancy怀孕终止370endocytic 内吞噬（胞饮）371endocytic activity内吞噬活性372endogenous agents内源性因子373endogenous components内源性物质374endogenous gene内源性基因375endogenous proteins内源性蛋白376endogenous retrovirus内源性逆转录病毒377endonuclease核酸内切酶378endonuclease release form ly
33、sosomes溶酶体释放核酸内切酶379endotoxins内毒素380end-point终点381end-product sterility test-ing最终产品的无菌试验382enhancers增强子383enveloped RNA viruses包膜RNA病毒384environmental factors环境因素385enzymatic reaction rates酶反应速率386enzyme酶387epididymal sperm maturation附睾精子成熟性388epitope表位389epitope抗原决定部位390Epstein-Barr virus(EBV)EB病毒
34、391equine马392error prone repair易错性修复393erythropoietins促红细胞生成素394escalation递增395escherichia coli starn大肠杆菌菌株396esscherichia coli 大肠杆菌397ethnic origin种族起源398eukaryotic cell真核细胞399evaluation of test result试验结果评价400ex vivo体外401exaggerated pharmacological response超常增强的药理作用402excipient赋形剂403excipient spec
35、ifications赋形剂规范404excretion排泄(消除)405expiration date/dating失效日期406exposure assessment 接触剂量评价407exposure level暴露程度408exposure period光照时间409exposure period接触期410expression constract表达构建体411expression system表达系统412expression vector表达载体413extended-release延时释放414extent of the virus test病毒测试的程度415external
36、metabolising system体外代谢系统416extinction coefficient消光系数417extrachromosomal染色体外418extraneous contaminants外源性污染物419extrapolation 外推法420F1-animals子一代动物421false negative result假阴性结果422false positive result假阳性结果423fecundity多产424feed-back反馈425fermentation发酵426fermentation products发酵产品427fertilisation受精428f
37、ertility生育力429fertility studies生育力研究430fetal abnormalities胎仔异常431fetal and neonatal parameters胎仔和仔鼠的生长发育参数432fetal development and growth胎仔发育和生长433fetal period 胎仔期434fetotoxicity胎仔毒性435fill volume装量436filter aids 过滤介质437final manufacturing最终生产438finished product成品439first pass testing 一期试验440flankin
38、g region侧翼区441fluorescence in situ hybridisation(FISH)原位荧光分子杂文442foetuses胎仔443forced degradation testing强制降解试验444foreign matter异质性物质445formal labeling正式标签446formal stability studies正式的稳定性研究447formulation 处方/配方448formulation 制剂449fragmentation片段化450frameshift mutation移码突变451frameshift point mutation移
39、码点突变452free-standing独立453freeze-dried product冻干产品454fresh dissection technique新鲜切片技术455friability脆碎度456functional deficits功能试验457functional test功能性指标458funetional indices融合蛋白459fungi真菌460fusion partners融合伴侣461fusion protein融合蛋白462fusion proteins配子463gametes动物性别464gel filtration 凝胶过滤465gender of anim
40、als性别专一性药物466gender-specific drug基因剔除467gene amplification基因扩增468gene knockout基因治疗469gene mutation基因突变470gene therapy基因疗法471generation of the cell substrate细胞基质的产生472genetic遗传473genetic change 遗传学改变474genetic damage遗传学损伤475genetic endpoint遗传终点476genetic manipulation基因操作477genetic toxicity遗传毒性478geno
41、mic dinucleotide repeats基因组双核苷酸重复数479genomic DNA基因组DNA480genomic polymorphism pattern基因组形态类型481genotoxic activity遗传毒性作用482genotoxic carcinogen遗传毒性致癌剂483genotoxic effect 遗传毒性效应484genotoxic hazard遗传毒性危害485genotoxic potential潜在遗传毒性486genotoxic rodent carcinogen啮齿类动物遗传毒性致癌剂487genotoxicity 遗传毒性488genotox
42、icity evaluation遗传毒性评价489genotoxicity test遗传毒性试验490genotoxicity test battery遗传毒性试验组合491genotypic 基因型492germ cell mutagen生殖细胞诱变剂493germ line mutation生殖系统突变494GLP临床前研究质量管理规范495glucose consumption rates耗糖率496glycoforms糖化形式497glycosylation糖基化498goegrapgical origin 地理起源499gross chromosomal damage 染色体大损伤5
43、00gross evaluation of placenta 胎盘的大体评价501growth factors生长因子502growth hormones 生长激素503guanidine胍504haematoxylin staining苏木素染色505half-life半衰期506hamster antibody production(HAP)test仓鼠抗体产生实验507Hantaan virus汉坦病毒508hardness硬度509heavy metals重金属510hematopoietic cells造血细胞511heparins肝素512heptachlor七氯化合物513her
44、bal products草药514heritable遗传515heritable defect遗传缺陷516heritable disease遗传性疾病517heritable effect 遗传效应518herpes virus 疱疹病毒519heterogeneities异质性520heterohybrid cell lines异种杂交细胞系521high concentration高浓度522high-resolution chromatography高分辨色谱523histologic appearance of reproductive organ生殖器官的组织学表现524histo
45、pathological chang组织病理学改变525homogeneity均一性526homologous proteins同系蛋白527homologous series同系528host cell 宿主细胞529host cell banks宿主细胞库530host cell DNA宿主细胞DNA 531host cell proteins宿主细胞蛋白质532hot-stage microscopy热价显微镜533human carcinogen人类致癌剂534human cell lines人细胞系535human diploid fibroblasts人二倍体成纤维细胞536hum
46、an lymphoblastoid TK6 cell 人成淋巴TK6细胞537human mutagen人类致突变剂538human polio virus人脊髓灰质炎病毒539human subjects人体540human tropism人向性541humidity湿度542humidity-protecting containers防湿容器543humoral immunity 体液免疫544hybridization techniques杂交技术545hybridoma cell杂交瘤细胞546hybridomas杂交瘤547hydrolysates水解物548hydrolytic e
47、nzymes水解酶549hydrophobicity疏水性550hygroscopic吸湿性551identification/identity鉴别552immature erythrocyte未成熟红细胞553immediate and latent effect速发和迟发效应554immediate container/closure直接接触的容器/密闭物555immediate pack内包装556immediate release立即释放557immortalization激活558immune spleen cells免疫脾细胞559immunoassay免疫检测560immunoc
48、hemical methods免疫化学方法561immunochemical properties免疫化学性质562immunoelectrophoresis免疫电泳563immunogenicity免疫原性564immunological interations免疫相互作用565immunopathological effects免疫病理反应566immunoreactivity免疫反应性567immunotoxicity免疫毒性568implantation着床569implantation sites着床部位570impurity profile杂质概况571in vitro体外572i
49、n vitro and in vivo inoculation tests体内和体外接种试验573in vitro assay体外检测574in vitro cell age体外细胞传代期575in vitro lifespan体外生命周期576in vitro test体外试验577in vitro tests体外试验578in vitro/in vivo correlation体内体外相关性579in vivo体内580in vivo assays体内检测581in vivo test体内试验582inactivated vaccine 灭活疫苗583incidence of polypl
50、oid cell 多倍体细胞发生率584incisor eruption门齿萌出585independent test独立试验586indicator cell指示细胞587indicator organisms指示菌588individual fetal body weight单个胎仔体重589indoor indirect daylight室内间接日光590induced and spontaneous models of disease诱发或自发的疾病模型591inducer of micronuclei微核诱导剂592inducers 诱导剂593inedntification tes