ICH领域专业术语表（质量、安全性）序号英文中文1 absorption 吸收2 acceptable daily intake 可接受的日摄入量3 accelerated test 加速试验4 acceptance criteia 认可标准5 accuracy 准确性6 accelerated/stress stability studies 加速/强力破坏稳定性研究7 action limits 内控限值8 active ingredient 活性组分9 active metabolite 活性代谢产物10 additional test 附加实验11 additions 添加剂12 adduct 加合物13 adequate exposure 充分暴露14 adjuvant 佐剂15 administration period 给药期16 adventitious agents 外源性因子17 adventitious contaminants 外来污染物18 adventitious viruses 外源病毒19 adverse reaction 不良反应20 aerobic microorganisms 需氧微生物21 affinity 亲和力22 affinity chromatography 亲和层析23 affinity column 亲和柱24 agar and broth 琼脂和肉汤25 aggregation 聚集26 altered growth 生长改变27 ambient condition 自然条件28 amino acid sequence 氨基酸顺序29 amino acids 氨基酸30 amino sugars 氨基糖31 analytical method 分析方法32 antibiotics 抗生素33 antibody 抗体34 antibody production tests 抗体产生试验35 antigenic specificity 抗原特异性36 applicant 申报者37 art and ethical standards 技术和伦理标准38 assessment of genotoxicity 遗传毒性评价39 attainment of full sexual function 达到性成熟40 avidity 亲和性41 background 背景42 bacteria 细菌43 base pairs 碱基对第 1 页共13 页44 base set of strains 基本菌株45 base substitution 碱基置换46 batches 批次47 batch-to-batch 逐批48 between-assay variation 试验间变异49 bioburden 生长量/生物负荷50 biochemical methods 生化方法51 biological products 生物制品52 biological relevance 生物学意义53 bioreactor 生物反应器54 birth 出生55 blood plasma factors 血浆因子56 body burden 机体负担57 body fluids 体液58 by-products 副产物59 C(time)一定剂量、某一时间的浓度60 calibrate 标化61 capillary electrophoresis 毛细管电泳62 carbohydrate 碳水化合物63 carboxy-terminal amino acids 羧基端氨基酸64 carcinogen 致癌物质65 carcinogenesis 致癌性66 carcinogenic hazard 致癌性危害67 carrier 载体/担体68 case-by-case 个例69 catalysts 催化剂70 cell bank 细胞库71 cell bank system 细胞库系统72 cell cultures 细胞培养物73 cell cultures 细胞培养74 cell expansion 细胞扩增75 cell fusion 细胞融合76 cell line 细胞系77 cell lines 细胞系78 cell metabolites 细胞代谢物79 cell pooling 细胞混合80 cell proliferation 细胞增植81 cell replication system 细胞复制系统82 cell substrates 细胞基质83 cell suspension 细胞悬液84 cell viability 细胞活力85 central nervous systems 中枢神经系统86 charcoal 活性炭87 charge 电荷88 chromatograms 色谱图89 chromatographic behavior 色谱行为第 2 页共13 页90 chromatographic procedures 色谱方法91 chromatography columns 色谱分离柱92 colony sizing 集落大小93 confidence interval 置信区间94 confidence limits 可信限95 consistency 一致性96 container 容器97 container/closure 容器/闭塞物98 container/closure integrity testing 容器/密封完整性试验99 contaminants 污染物100 content uniformity 含量均匀度101 continuous treatment 连续接触102 control methodology 控制方法学103 controlled released product 控释制剂104 conventional live virus vaccines 传统的活病毒疫苗105 conventional vaccines 传统疫苗106 correction factor 校正因子107 correlation coefficient 相关系数108 cross-contamination 交叉污染109 cross-linking agent 交联剂110 cross-reactivity 交叉反应111 cryopreservation 冷冻保存112 cryoprotectants 防冻剂113 crystals 晶体114 culture components 培养基成分115 culture condiction 培养条件116 culture media/medium 培养基117 decision flow chart/tree 判断图118 Degradation 降解产物119 degradation 降解120 degradation pathway 降解途径121 degree of scatter 离散程度122 delay of parturition 分娩延迟123 descriptive statistics 描述性统计124 detection limit 检测限度125 dissolution testing 溶出试验126 dissolution time 溶出时间127 distribution 分布128 dosage form 剂型129 dose dependence 剂量依赖关系130 dose level 剂量水平131 dose -limiting toxicity 剂量限制性毒性132 dose-ranging studies 剂量范围研究133 dose-related 剂量相关134 dosing route 给药途径135 downstream purification 下游纯化第 3 页共13 页136 drug product 制剂137 drug product components 制剂组方138 drug substances 原料药139 duration 周期140 endotoxins 内毒素141 end-point 终点142 end-product sterility testing 最终产品的无菌试验143 enhancers 增强子144 enzyme 酶145 evaluation of test result 试验结果评价146 ex vivo 体外147 excipient 赋形剂148 expiration date/dating 失效日期149 exposure assessment 接触剂量评价150 exposure level 暴露程度151 exposure period 接触期152 expression system 表达系统153 expression vector 表达载体154 extended-release 延时释放155 extent of the virus test 病毒测试的程度156 false negative result 假阴性结果157 false positive result 假阳性结果158 fecundity 多产159 feed-back 反馈160 fermentation 发酵161 fermentation products 发酵产品162 fill volume 装量163 filter aids 过滤介质164 final manufacturing 最终生产165 finished product 成品166 first pass testing 一期试验167 forced degradation testing 强制降解试验168 formal labeling 正式标签169 formal stability studies 正式的稳定性研究170 formulation 处方/配方171 formulation 制剂172 freeze-dried product 冻干产品173 fresh dissection technique 新鲜切片技术174 friability 脆碎度175 functional deficits 功能性指标176 functional test 功能试验177 growth factors 生长因子178 growth hormones 生长激素179 half-life 半衰期180 hardness 硬度181 heavy metals 重金属第 4 页共13 页182 herbal products 草药183 host cell 宿主细胞184 host cell banks 宿主细胞库185 host cell DNA 宿主细胞DNA186 host cell proteins 宿主细胞蛋白质187 humidity 湿度188 humidity-protecting containers 防湿容器189 immediate container/closure 直接接触的容器/密闭物190 immediate pack 内包装191 immediate release 立即释放192 immortalization 激活193 in vitro 体外194 in vitro and in vivo inoculation tests 体内和体外接种试验195 in vitro assay 体外检测196 in vitro cell age 体外细胞传代期197 in vitro lifespan 体外生命周期198 in vitro test 体外试验199 in vitro tests 体外试验200 in vitro/in vivo correlation 体内体外相关性201 in vivo 体内202 in vivo assays 体内检测203 in vivo test 体内试验204 inactivated vaccine 灭活疫苗205 independent test 独立试验206 indicator cell 指示细胞207 indicator organisms 指示菌208 influenza virus 流感病毒209 inhalation 吸入210 inhalation dosage forms 吸入剂型211 in-house 内部的212 in-house criterea 内控标准213 initial filing 原始文件214 initial submission 最初申报215 initial text 最初文本216 inoculation 接种217 inorganic impurities 无机杂质218 inorganic mineral 无机矿物质219 inorganic salts 无机盐220 in-process acceptance criteia 生产过程认可标准221 in-process controls 生产过程中控制222 in-process testing 生产过程中检测223 intended effect 预期效果224 intended storage period 预期的贮藏期225 intentional degradation 人为降解226 interactions 相互作用227 intermediate 中间体第 5 页共13 页228 intermediates 半成品229 internal control 内对照230 international reference standards 国际参比标准品231 ion-exchange 离子交换232 ionic content 离子含量233 isoelectric focusing/isoelectrofocusing 等电聚焦234 Jp/Ph.Eur./Usp. 日本药局方/欧洲药典/美国药典235 Level of safety 安全水平236 Libido 性欲237 Life threatering 危及生命238 ligand 配位体/配体239 light 光照240 light resistant packaging 避光包装241 limit of acceptance 可接受的限度242 limit test 限度试验243 limulus amoebocyte lysate 鲎试剂244 linear relation ship 线性关系245 linearity 线性246 liquid nitrogen 液氮247 liquid oral dosage forms 液体口服制剂248 long term test 长期试验249 Long-term carcinogenicity study 长期致癌性试验250 long-time and accelerated stability 长期和加速稳定性试验251 Loss of the tk gene tk 基因丢失252 losses of activity 活性丧失253 lot release 批签发254 low molecular weight subsances 低分子量物质255 lower-observed effect level (LOEL) 能观察到反应的最低量256 manufacturing scale 生产规模257 marieting pack 上市包装258 marker chromosome 标志染色体259 Marketing approval 上市许可260 mass 重量261 mass balance 质量平衡262 mass spectrometry 质谱263 master cell bank (MCB) 主细胞库264 matrixing 每日最大剂量265 Metabolism 代谢266 microbial expression system 微生物表达系统267 microbial limits 微生物限度268 microbial metabolites 微生物代谢物269 microbiological testing 微生物学试验270 Micronucleus 微核271 minimum of pilot plant 试产规模272 moisture level 水分273 primary structure 一级结构第 6 页共13 页274 primer 引物275 probability 概率276 process controls 工艺控制277 process optimisation 工艺优化278 process parameters 工艺参数279 process validation 工艺确证280 process-related impurities 工艺相关杂质281 Pro-drug 前体药物282 product-related imputies 产品相关杂质283 promoters 启动子284 proposed commercial process 模拟上市285 protected samples 避光样品286 proteins 蛋白质287 proteolysis 蛋白水解288 protocol 方案289 purification 纯化290 purified antigens 纯化抗原291 purity 纯度292 purity test 纯度试验293 pyrogens 热原294 qualification 界定295 qualified 合格的296 quality standards 质量标准297 quantitation limit 定量限度298 quantitative characteristics 定量参数299 quantitative detection 定量检测300 quantitative method 定量方法301 quantitative test 定量试验302 quantitative virus assays 病毒定量分析303 quantity 含量304 reagent 试剂、反应物305 real condition 真实条件306 real time 真实时间307 receptor 受体308 reference standard 参比标准品309 regimen 方案310 registration application 注册申请311 regression analysis 回归分析312 related substances 有关物质313 release limit 出厂限度314 Relevant animal species 相关动物种属315 Relevant dose 相关剂量316 Relevant factor 相关因素317 repeatability 重复性318 reproducibility 重现性319 residual lolvents content 溶剂残留量第7 页共13 页320 residual solvents 残留溶剂321 retention time 保留时间322 retest date 再试验日期323 Reversibility 可恢复性（可逆性）324 revived cells 复苏的细胞325 Risk assessment 危险度评价326 Route of administration 给药途径327 Routine testing 常规试验328 Safegards 安全监测329 Safety margin 安全范围330 Safety pharmacology 安全药理学331 sampling 采样332 Sampling time 采样时间333 scale-up 放大334 scaling down 缩小规模335 scope 范围336 scrapie 瘙痒病337 screening tests 筛选试验338 SDS-PAGE/SDS-polyacrylamide gelelectrophoresis十二烷基磺酸钠-聚丙烯酰胺凝胶电泳339 sealed ampoules 密封安瓿340 secondary structure 二级结构341 Secondary testing 二期试验342 self-replicating agents 自我复制因子343 semi-synthetic products 半成品产品344 Sensitive periods 敏感期345 sensitivity 灵敏度346 serum 血清347 shelf life 货架寿命348 shipmjent 运输349 Short term toxicity 短期毒性350 Short treatment 短期处理351 Single dose(acute)toxicity 单剂量（急性）毒性352 single-dose and multipledose packages 单剂量和多剂量包装353 Site-specific targeted delivery 定位靶向释放354 Small colony 小集落355 solid oral doseage 固体口服制剂356 solvent 溶剂357 Solvent control 溶剂对照358 Somatic cell 体细胞359 specification 规范360 specification limit 规范限度361 specification-check 质控规范362 specification-release 出厂规范363 stability data 稳定性资料364 stability evaluation 稳定性评价第8 页共13 页365 stability protocol 稳定性方案366 stability study duration 稳定性试验期限367 stability testing 稳定性试验368 standard deviation 标准差369 Standard procedure 标准规程370 Standard protocol 标准试验方案371 starting materials 起始物372 statement/labelling 说明/标签373 statistical analysis 统计学分析374 Statistical evaluation 统计学评价375 Step-by-step 逐步376 sterility 无菌377 storage condition 放置条件378 stress condition 强力破坏试验条件379 stress testing 强力破坏试验380 strorage conditions 贮存条件381 Structural changes 结构改变382 Suspension 悬浮物383 suspensions 混悬剂384 synthesis 合成385 synthetic peptides 合成肽386 Target cell 靶细胞387 Target histidine genes 组氨酸目的基因388 target molecule 靶分子389 Target organs 靶器官390 Target tissue 靶组织391 temperature changes 温度变化392 teriary structure 三级结构393 terminology 术语394 Test approach 试验方法395 Test battery approach 试验组合方法396 Test compound 受试物397 test criteria 试验标准398 test intervals 试验间隔399 Test model 试验模型400 test parameters 试验参数401 Test strategy 试验策略402 Test systems 试验系统403 Tester strain 试验菌株404 testing frequency 试验次数405 Therapeutic 治疗406 Therapeutic confirmatory 疗效确定407 Therapeutic exploratory 疗效探索408 Therapeutic indication 治疗适应证409 threshold limits 阈值410 Time course 时程第9 页共13 页411 Timing conventions 分段计时方法412 titration 滴定法413 tolerable daily intake 可耐受的日摄入量414 Top concentration 最高浓度415 Topical 局部的416 transcription 转录417 transdermal systems 透皮吸收系统418 transfection 转染419 transformation 转化420 Translocation 移位421 Tumor response 肿瘤反应422 tumorigenicity 致瘤性423 uniformity of content 含量均匀度424 universal tests/criteria 常规试验/标准425 UV/visible wavelength 紫外/可见光波长426 vaccines 疫苗427 validation 论证428 variants 变异体429 vector 载体430 visual appearance 外观431 visual evaluation 直观评价432 vitamins 维生素433 western blot 免疫印迹434 Whole blood 全血435 working cell bank 工作细胞库436 yeast 酵母437 y-intercept y轴上的截距FDA有关术语FDA（food and drug administration) （美国）食品药品管理局IND（investigational new drug）临床研究申请NDA（new drug application）新药申请ANDA（abbreviated new drug application 新药简化申请EP （export application）出口药申请Treatment ind 研究中的新药用于治疗Abbreviated（new）drug 药物简化申请DMF（drug master file 药物主控文件第10 页共13 页holder dmf持有者CFR（code of federal regulation）（美国）联邦法规panel 专家小组batch production 批量生产；分批生产batch production records 批生产记录post-or pre- market surveillance 销售前或销售后监督informed consent 知情同意prescription drug 处方药OTC drug（over—the—counter drug）非处方药US．public health service 美国卫生福利部NIH（national institute of health）（美国）全国卫生研究所clinical trial 临床试验animal trial 动物试验accelerated approval 加速批准standard drug 标准药物investigator 研究人员；调研人员preparing and submitting 起草和申报submission 申报；递交benifit（s）受益risk（s）受害，风险drug product 药物产品drug substance 原料药established name 确定的名称generic name 非专利名称proprietary name 专有名称INN（international nonproprietary name）国际非专有名称，通用名narrative summary 记叙体概要adverse effect 副作用adverse reaction 不良反应protocol 方案archival copy 存档用副本review copy 审查用副本official compendium 法定药典（主要指USP\NF）USP（the united states pharmacopeia）美国药典（现已和nf合并一起出版）NF（national formulary) （美国）国家药品集official＝pharmacopeial= compendial 药典的；法定的；官方的agency 审理部门（指FDA）sponsor 主办者（指负责并着手临床研究者）identity 真伪；鉴别；特性strength 规格；规格含量labeled amount 标示量regulatory specification 质量管理规格标准（nda提供）regulatory methodology 质量管理方法regulatory methods validation 管理用分析方法的验证dietary supplement 食用补充品第11 页共13 页欧盟GMP附录术语Air-lock 气锁Batch (or lot) 批Batch number (or lot number) 批号 Biogenerator 生物反应器 Biological agents 生物载体Bulk product 待包装产品 Calibration 校准Cell bank 细胞库Cell culture 细胞培养物 Clean area 洁净区Clean/contained area 洁净/隔离区域 Containment 隔离Contained area 隔离区域 Controlled area 控制区/受控区域 Computerized system 计算机化的系统 Cross contamination 交叉污染Crude plant (Vegetable drug) 天然植物 Cryogenic vessel 低温容器 Cylinder 气体钢瓶Exotic organism 外来生物体 Finished product 成品Herbal medicinal product 草本药物产品 Infected 感染In-process control 中间控制 Intermediate product 中间产品 Liquefiable gases 液化的气体 Manifold 多支管灌装头 Manufacturer 制造企业 Medicinal plant 药用植物 Packaging 包装 Packaging material 包装材料 Procedures 规程 Production 生产 Qualification 确认Quality control 质量控制 Quarantine 待检 Radiopharmaceutical 放射性药品 Reconciliation 数额平衡 Record 记录Recovery 回收 Reprocessing 返工处理 Return 退货/退回Seed lot 种子批第12 页共13 页Specification 质量标准/规格 Starting material 起始物料 Sterility 无菌System 系统 Validation 验证第13 页共13 页。