ICH术语表.xls
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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
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