cap liner capillary electrophoresis carbohydrate carboxy-terminal amino acids carrier catalysts cell bank cell bank system cell banking procedures cell banking system cell culture-derived impurities cell cultures cell expansion cell lines cell metabolites cell pooling cell substrate-derived impurities cell substrates cell viability cell-derived biological products cell fusion cellular blood components cemadsorbing viruses characterization and testing of cell banks charcoal charge chemical actinometric system chemical reactivity chemical syntheses chemically inert chewable tablets chiral impurities chromatograms chromatographic behavior chromatographic procedures chromatography columns circular dichroism clearance studies climatic zones clinical research clinical trial application
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中英文对照术语表(ICH 质量)
英文
中文
abbreviated or abridged aplication
简略申请
abnormal karyology
异常核形
absorbed moisture
吸附水
acceptable daily intake
可接受的日摄入量
acceptable test
改变的结合物形式
ambient condition
自然条件
amino acid composition
氨基酸组成
amino acid sequence
氨基酸顺序
amino acids
氨基酸
amino sugars
氨基糖
amino-terminal amino acids
氨基端氨基酸
ammonia production Rates
内控限值
active components/comcound/moiety
活性成分
active ingredient
活性组分
adaption to specific culture conditions
特定培养条件的适应
additives
添加剂
adjuvant
佐剂
adventitious agents
产氨率
analyte
被测物
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analytical procedure animal cell lines animal tissues or organs antennary profile antibiotic resistance genes antibiotics antibody antibody production tests antisera applicant ascites assay assay procedure avian avidity background bacteria batches batch-to-batch between-assay variation binary fission binding assays bioburden biochemical methods bioequivalency biohazard information biological activity biological products bioreactor biotechnological/biological products biotechnological products biphasic curve blood plasma factors body fluids bovine bovine spongiform encephalopathy (BSE) bracketing breeding conditions by-products calibrate canine
需氧微生物
affinity
亲和力
affinity chromatography
亲和层析
affinity column
亲和柱
agar and broth
琼脂和肉汤
aggregates
聚合体
aggregation
聚集
allergenic/allergic extracts
过敏原抽提物
altered conjugated forms
外源性因子
adventitious contaminants
外来污染物
adventitious viral or mycoplasma contamination
外源性病毒或支原体污染
adventitious viruses
外源病毒
adverse reaction
不良反应
aerobic microorganisms
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分析方法 动物细胞系 动物组织或器官 触角形状 抗生素耐药基因 抗生素 抗体 抗体产生试验 抗血清 申报者 腹水 含量测定 定量方法 鸟类 亲和性 背景 细菌 批次 逐批 试验间变异 双数分裂 结合试验 生长量／生物负荷 生化方法 生物等效性 生物有害信息 生物活性 生物制品 生物反应器 生物技术／生物制品 生物技术产品 双相曲线 血浆因子 体液 牛 疯牛病 括号法 饲养条件 副产物 标化 犬
加速试验
acceptance criteria
认可标准
accuracy
准确性
acelerated/stress stability Studies
加速/强力破坏稳定性研究
ace assay
非手性测定
achlorhydric elderly
老年性胃酸缺乏症
action limits