文件内容来源于国家药监局关于发布《M4：人用药物注册申请通用技术文档（CTD）》模块一文件及CTD中文版的通告（2019年第17号）的文件。
链接地址：https://www.nmpa.gov.cn/directory/web/nmpa/xxgk/ggtg/qtggtg/20190417174001488.html
M4术语表
| 序号 | 英文原文 | 中文翻译 |
| 1 | Adventitious agents | 外源因子 |
| 2 | Active controlled trials | 阳性对照试验 |
| 3 | Applicant | 申请人 |
| 4 | Brief summary | 简要总结 |
| 5 | Benefits and risks conclusions | 获益与风险结论 |
| 6 | Biopharmaceutic studies | 生物药剂学研究 |
| 7 | Bioavailability | 生物利用度 |
| 8 | Bioequivalence | 生物等效性 |
| 9 | Clinical overview | 临床综述 |
| 10 | Clinical summary | 临床总结 |
| 11 | Clinical study reports | 临床研究报告 |
| 12 | Clinical efficacy | 临床有效性 |
| 13 | Clinical safety | 临床安全性 |
| 14 | Clinical Pharmacology | 临床药理学 |
| 15 | Control strategy | 控制策略 |
| 16 | Compendial monographs | 药典各论 |
| 17 | Critical steps | 关键步骤 |
| 18 | Compendial | 药典 |
| 19 | Controlled clinical trials | 对照临床试验 |
| 20 | Control of materials | 物料控制 |
| 21 | Common technical document | 通用技术文档 |
| 22 | Concentration | 浓度 |
| 23 | Container closure system | 包装系统 |
| 24 | Drug product | 制剂 |
| 25 | Double blind, active controlled trial | 双盲、阳性对照试验 |
| 26 | Drug substance | 原料药/原液 |
| 27 | Dosage form | 剂型 |
| 28 | Double blind, placebo-controlled trial | 双盲、安慰剂对照试验 |
| 29 | Equipment | 设备 |
| 30 | Excipient | 辅料 |
| 31 | Efficacy | 有效性 |
| 32 | Facility | 设施 |
| 33 | Findings | 结果 |
| 34 | Guidance | 指南 |
| 35 | Granularity document | 粒度文件 |
| 36 | General information | 基本信息 |
| 37 | General glossary of terms | 通用术语表 |
| 38 | General principles | 一般原则 |
| 39 | Introduction | 引言 |
| 40 | Indication | 适应症 |
| 41 | Intermediates | 中间体 |
| 42 | Individual studies | 单项研究 |
| 43 | Impurities | 杂质 |
| 44 | Labeling | 说明书 |
| 45 | Level | 层级 |
| 46 | Manufacturing process | 生产工艺 |
| 47 | Manufacturer | 生产商 |
| 48 | Manufacture | 生产 |
| 49 | Nonclinical overview | 非临床综述 |
| 50 | Nonclinical study reports | 非临床试验报告 |
| 51 | Overview | 综述 |
| 52 | Quality overall summary | 质量综述 |
| 53 | Pharmacodynamics(PD) | 药效动力学 |
| 54 | Pharmacology | 药理学 |
| 55 | Pharmacokinetics | 药代动力学 |
| 56 | Placebo controlled trials | 安慰剂对照试验 |
| 57 | Quality | 质量 |
| 58 | Plasma protein binding | 血浆蛋白结合 |
| 59 | Reference standards or materials | 对照品 |
| 60 | Reconstitution diluent(s) | 复溶稀释剂 |
| 61 | Strength | 规格 |
| 62 | Storage condition | 贮藏条件 |
| 63 | Section | 章节 |
| 64 | Subsection | 子章节 |
| 65 | Summary | 总结 |
| 66 | Stability data | 稳定性数据 |
| 67 | Safety | 安全性 |
| 68 | Structure | 结构 |
| 69 | Tabulated summary | 列表总结 |
| 70 | Toxicology | 毒理学 |
| 71 | Written summary | 文字总结 |
M4E专业术语表
| 序号 | 英文原文 | 中文翻译 |
| 1 | Accumulation of the parent drug and its metabolite | 母体药物和其代谢物的蓄积 |
| 2 | Accuracy | 准确度 |
| 3 | Active control | 阳性对照 |
| 4 | Adverse event | 不良事件 |
| 5 | Area-under-curve | 曲线下面积 |
| 6 | Benefit-Risk assessment | 获益-风险评估 |
| 7 | Benefits and Risks | 获益与风险 |
| 8 | Bioavailability (BA) | 生物利用度 |
| 9 | Bioequivalence (BE) | 生物等效性 |
| 10 | Biopharmaceutics | 生物药剂学 |
| 11 | Blinding | 盲法 |
| 12 | Bridging study | 桥接研究 |
| 13 | Case report form | 病例报告表 |
| 14 | Causal relationship | 因果关系 |
| 15 | Clearance | 清除率 |
| 16 | Clinical efficacy | 临床有效性 |
| 17 | Clinical endpoint | 临床终点 |
| 18 | Clinical pharmacology | 临床药理学 |
| 19 | Clinical safety | 临床安全性 |
| 20 | Clinical study | 临床研究 |
| 21 | Clinical study report | 临床研究报告 |
| 22 | clinical summary | 临床总结 |
| 23 | Clinical trial | 临床试验 |
| 24 | Clinical variation | 临床变更 |
| 25 | Comparative bioavailability (BA) | 相对生物利用度 |
| 26 | Concentration-response relationship | 浓度-效应关系 |
| 27 | Concomitant illness | 合并症 |
| 28 | Concomitant therapy | 合并治疗 |
| 29 | Control group | 对照组 |
| 30 | Controlled clinical study | 对照临床研究 |
| 31 | Convenience | 依从性 |
| 32 | Current therapy | 现有治疗手段 |
| 33 | Disease or condition | 疾病或身体状况 |
| 34 | Dosage form | 剂型 |
| 35 | Dosage form proportionality study | 剂型比例研究 |
| 36 | Dose | 剂量 |
| 37 | Dose-response relationship | 剂量-效应关系 |
| 38 | Drug | 药物 |
| 39 | Drug abuse | 药物滥用 |
| 40 | Drug interaction | 药物相互作用 |
| 41 | Drugs used off-label | 超说明书用药 |
| 42 | Efficacy | 有效性 |
| 43 | Enrichment strategy | 富集策略 |
| 44 | Enzymatic pathway | 酶通路 |
| 45 | Equivalence | 等效性 |
| 46 | Ethnic factor | 种族因素 |
| 47 | Exposure to the drug | 药物暴露 |
| 48 | Extrinsic factor PK study | 外在因素 PK 研究 |
| 49 | Food-effect study | 食物-效应研究 |
| 50 | Formulation | 制剂 |
| 51 | Guidance | 指南 |
| 52 | Genetic difference | 遗传差异 |
| 53 | Genetic polymorphism | 遗传多态性 |
| 54 | Granularity document | 粒度文件 |
| 55 | Healthy subject PK | 健康受试者 PK |
| 56 | hepatic metabolism | 肝脏代谢 |
| 57 | Incidence | 发病率 |
| 58 | Indication | 适应症 |
| 59 | Individual patient listing | 个体患者列表 |
| 60 | Initial tolerability study | 初始耐受性研究 |
| 61 | Integrated summary of effectiveness (ISE) | 有效性综合总结 |
| 62 | Integrated summary of safety (ISS) | 安全性综合总结 |
| 63 | Intrinsic factor PK study | 内在因素 PK 研究 |
| 64 | Key benefit | 主要获益 |
| 65 | Key risk | 主要风险 |
| 66 | Labeling | 说明书 |
| 67 | Leaf element | 子元素 |
| 68 | Mass balance | 物料平衡 |
| 69 | Maximum plasma concentration | 血浆峰浓度 |
| 70 | Meta-analysis | 荟萃分析 |
| 71 | Metabolic pathway | 代谢通路 |
| 72 | Missing data | 缺失数据 |
| 73 | Misuse | 误用 |
| 74 | Morbidity | 患病率 |
| 75 | Mortality | 死亡率 |
| 76 | Narrative | 叙述性描述 |
| 77 | Non-inferiority margin | 非劣效界值 |
| 78 | Non-inferiority trial | 非劣效性试验 |
| 79 | Non-serious adverse event | 非严重不良事件 |
| 80 | Open extension study | 开放性扩展研究 |
| 81 | Overall extent of exposure | 总体暴露程度 |
| 82 | Overdose | 药物过量 |
| 83 | Overview | 综述 |
| 84 | Peak exposure | 暴露量峰值 |
| 85 | Pharmacodynamics | 药效动力学 |
| 86 | Pharmacokinetic(pk) | 药代动力学 |
| 87 | Pharmacovigilance | 药物警戒 |
| 88 | Placebo | 安慰剂 |
| 89 | Polymorphic metabolism. | 代谢多态性 |
| 90 | Population PK study | 群体 PK 研究 |
| 91 | Post hoc exercise. | 事后分析 |
| 92 | Preamble | 前言 |
| 93 | Precision | 精密度 |
| 94 | Primary study endpoint | 主要研究终点 |
| 95 | Randomisation | 随机化 |
| 96 | Rebound | 反跳 |
| 97 | Reliability | 可靠性 |
| 98 | Results across studies | 研究间结果 |
| 99 | Results of individual study | 单项研究结果 |
| 100 | Risk management | 风险管理 |
| 101 | Safety | 安全性 |
| 102 | Sensitivity | 灵敏度 |
| 103 | Serious adverse event | 严重不良事件 |
| 104 | Significant adverse event | 重要不良事件 |
| 105 | Single and repeated-dose PK | 单次给药和重复给药 PK |
| 106 | Sparse sampling | 稀疏采样 |
| 107 | Specificity | 特异性 |
| 108 | Sub-groups | 亚组 |
| 109 | Sub-population | 亚群 |
| 110 | Superiority | 优效性 |
| 111 | Surrogate endpoint | 替代终点 |
| 112 | Susceptibility | 易感性 |
| 113 | Therapeutic context | 治疗背景 |
| 114 | Tolerability | 耐受性 |
| 115 | Tolerance | 耐药 |
| 116 | Total exposure | 总暴露量 |
| 117 | Treatment duration | 治疗持续时间 |
| 118 | Uncontrolled clinical study | 非对照临床研究 |
| 119 | Vitro dissolution | 体外溶出度 |
| 120 | Withdrawal | 撤药 |
| 121 | Written summary | 文字总结 |
M4Q 专业术语表
| 序号 | 英文原文 | 中文翻译 |
| 1 | Acceptance criteria | 可接受标准 |
| 2 | Active moiety | 活性成分 |
| 3 | Additives | 添加剂 |
| 4 | Adventitious agents | 外源因子 |
| 5 | Analytical procedures | 分析方法 |
| 6 | Anti-microbial | 抑菌剂 |
| 7 | Antimicrobial preservatives | 抑菌防腐剂 |
| 8 | Antioxidants | 抗氧剂 |
| 9 | Aseptic | 无菌 |
| 10 | Appendices | 附录 |
| 11 | Batch analyses | 批分析 |
| 12 | Batch data | 批数据 |
| 13 | Batch Formula | 批处方 |
| 14 | Batch numbers | 批号 |
| 15 | Batch reproducibility | 批间重现性 |
| 16 | Batch(es) and scale definition | 批和批量的定义 |
| 17 | Batch size or scale | 批量或规模 |
| 18 | Bioanalytical Methods | 生物分析方法 |
| 19 | Biological activity | 生物活性 |
| 20 | Biological fluids | 生物体液 |
| 21 | Biological origin / Biologically- sourced | 生物源性 |
| 22 | “Biotech”/Biotech drug/Biotech products | 生物技术产品 |
| 23 | Body of data | 主体数据 |
| 24 | Buffers | 缓冲液 |
| 25 | Catalysts | 催化剂 |
| 26 | Cell banking system | 细胞建库系统 |
| 27 | （working）Cell bank | （工作）细胞库 |
| 28 | Cell culture, harvest(s), purification and modification | 细胞培养、收获、纯化和修饰 |
| 29 | Cell line | 细胞系 |
| 30 | Cell substrate | 细胞基质 |
| 31 | Certificates of analysis | 检验报告 |
| 32 | Characterisation | 特性鉴定 |
| 33 | Characterisation of impurities | 杂质分析 |
| 34 | Characteristic features | 特征 |
| 35 | Chromatograms | 色谱图 |
| 36 | Chromatography resins | 色谱树脂 |
| 37 | Co-administered drugs | 联合用药 |
| 38 | Common name | 通用名称 |
| 39 | Comparative analytical | 可比性分析 |
| 40 | Compendial monograph | 药典各论 |
| 41 | Compendial name | 药典名称 |
| 42 | Comptibility | 相容性 |
| 43 | Consistency | 一致性 |
| 44 | Constitution | 复溶 |
| 45 | Container closure system | 包装系统 |
| 46 | Control of materials | 物料控制 |
| 47 | Controlled release drug products | 控释制剂 |
| 48 | Critical controls | 关键控制 |
| 49 | Critical parameters | 关键参数 |
| 50 | Key parameters | 主要参数 |
| 51 | Critical steps | 关键步骤 |
| 52 | Cross reactivity studies | 交叉反应试验 |
| 53 | Cross-contamination | 交叉污染 |
| 54 | Cross-reference | 交叉引用 |
| 55 | Culture media | 培养基 |
| 56 | Dissolution performance | 溶出行为 |
| 57 | Dissolution profiles | 溶出曲线 |
| 58 | Dosage devices | 给药装置 |
| 59 | Dosage form | 剂型 |
| 60 | Drug Master Files（DMFs） | 药物主文件 |
| 61 | Drug product | 制剂 |
| 62 | Drug substance | 原料药 |
| 63 | Elution profiles | 洗脱图 |
| 64 | Endogenous and adventitious agents | 内源因子及外源因子 |
| 65 | End-product / finished /final product test | 成品检验 |
| 66 | Enzymes | 酶 |
| 67 | Executed Batch Record | 执行批记录 |
| 68 | Excipients | 辅料 |
| 69 | Expression construct | 表达系统 |
| 70 | Extractable | 可提取物 |
| 71 | Facilities and equipments | 设施和设备 |
| 72 | Filling procedure | 灌装程序 |
| 73 | Flow diagram | 工艺流程图 |
| 74 | Formulation | 处方 |
| 75 | Forced degradation studies | 强制降解研究 |
| 76 | Genetically modify | 基因修饰 |
| 77 | Glycoforms | 糖型 |
| 78 | Glycosylation sites | 糖基化位点 |
| 79 | Higher order structure | 高级结构 |
| 80 | Holding times | 放置时间 |
| 81 | Human or animal origin | 人源或动物源 |
| 82 | Immunological activity | 免疫活性 |
| 83 | Immunochemical properties | 免疫化学性质 |
| 84 | Impurity | 杂质 |
| 85 | Inactivate | 灭活 |
| 86 | Incompatibility | 不相容 |
| 87 | Initial cell clone | 起始细胞克隆 |
| 88 | Injection vessels | 注射器 |
| 89 | In-line homogeniser | 在线均质机 |
| 90 | Inoculum | 接种物 |
| 91 | International Nonproprietary Name（INN） | 国际非专利药品名称 |
| 92 | In-use storage conditions | 使用中贮藏条件 |
| 93 | Intermediates | 中间体 |
| 94 | Ionic strength | 离子强度 |
| 95 | In vitro studies | 体外研究 |
| 96 | In vivo studies | 体内研究 |
| 97 | Justification of specification | 质量标准制定依据 |
| 98 | Leaching | 浸出 |
| 99 | Leachable | 浸出物 |
| 100 | Manipulation | 处理/操作 |
| 101 | Manufacture | 生产 |
| 102 | Manufacturing control | 生产控制 |
| 103 | Manufacturing process development | 生产工艺开发 |
| 104 | Manufacturing processes | 生产工艺 |
| 105 | Manufacturing schemes | 生产流程 |
| 106 | Manufacturing site | 生产场地 |
| 107 | Master Cell Bank | 主细胞库 |
| 108 | Materials of construction | 结构材料 |
| 109 | Measures implemented | 控制措施 |
| 110 | Media components | 培养基组分 |
| 111 | Microbiological attributes | 微生物属性 |
| 112 | Monoclonal antibodies | 单克隆抗体 |
| 113 | Multiple Containers | 多种包装系统 |
| 114 | NCE | 新化学实体 |
| 115 | Nomenclature | 药品名称 |
| 116 | Non-compendial methods | 非药典方法 |
| 117 | Noncompendial | 药典未收载 |
| 118 | Non-proprietary name | 非专有名称 |
| 119 | Non-viral adventitious agents | 非病毒性外源因子 |
| 120 | Novel excipients | 新型辅料 |
| 121 | Operational parameters | 操作参数 |
| 122 | Overages | 过量投料 |
| 123 | Over-fill | 过量灌装 |
| 124 | Particle size distribution | 粒度分布 |
| 125 | Penetration enhancers | 促渗剂 |
| 126 | Performance | 性能 |
| 127 | Personnel | 人员 |
| 128 | Pharmaceutical development | 产品开发 |
| 129 | Physicochemical characteristics | 理化性质 |
| 130 | Pilot batch | 中试批次 |
| 131 | Population doubling levels | 倍增水平 |
| 132 | Post-translational modifications | 翻译后修饰 |
| 133 | Potency | 效价 |
| 134 | Production scale batch | 生产规模批次 |
| 135 | Primary structure | 一级结构 |
| 136 | Primary packaging | 初级包装 |
| 137 | Prions | 朊病毒 |
| 138 | （in）Process test | 过程中检测 |
| 139 | Process attributes | 工艺属性 |
| 140 | Process changes | 工艺变更 |
| 141 | Process controls | 工艺控制 |
| 142 | Process validation | 工艺验证 |
| 143 | Production scheduling | 生产计划 |
| 144 | Product-related substances | 产品相关物质 |
| 145 | Proposed commercial process | 拟定的商业化工艺 |
| 146 | Proprietary name | 专有名称 |
| 147 | Purification steps | 纯化步骤 |
| 148 | Purity | 纯度 |
| 149 | Quality | 质量 |
| 150 | Quality module | 质量模块 |
| 151 | Quality overall summary (QOS) | 质量综述 |
| 152 | Raw materials | 原材料 |
| 153 | Reagents | 试剂 |
| 154 | Reconstitution diluent | 复溶稀释剂 |
| 155 | Reduction factors for viral clearance | 病毒清除研究中病毒下降系数 |
| 156 | Reference Standards or Materials | 对照品/标准品 |
| 157 | Regeneration of columns | 色谱柱的再生 |
| 158 | Regional Information | 区域性信息 |
| 159 | Release specifications | 放行标准 |
| 160 | Reprocessing | 返工 |
| 161 | Retest date | 复检日期 |
| 162 | Route of administration | 给药途径 |
| 163 | Scaled-down model | 缩小规模模型 |
| 164 | Scale-up batch | 放大批次 |
| 165 | Secondary / tertiary / quaternary structures | 二级/三级/四级结构 |
| 166 | Secondary packaging | 次级包装 |
| 167 | Sensitivity | 灵敏度 |
| 168 | Shelf-life | 有效期 |
| 169 | Skip testing | 跳检 |
| 170 | Sorption | 吸附 |
| 171 | Specifications | 质量标准 |
| 172 | Specificity | 专属性 |
| 173 | Stability | 稳定性 |
| 174 | Starting materials | 起始物料 |
| 175 | Statistical analysis | 统计分析 |
| 176 | Stress studies | 强力试验 |
| 177 | Storage condition | 贮藏条件 |
| 178 | Structural characterisation | 结构确证 |
| 179 | Supporting data | 支持性数据 |
| 180 | Tabulated summary | 汇总表 |
| 181 | Terminal sterilization | 终端灭菌 |
| 182 | Transmissible spongiform encephalopathy agents | 传染性海绵状脑病病原体 |
| 183 | Unit operations | 单元操作 |
| 184 | Unprocessed bulk | 未加工收获物 |
| 185 | Viral clearance | 病毒清除 |
| 186 | Waste | 废弃物 |
| 187 | Water content | 水分 |
| 188 | Working capacity | 生产能力 |
M4S专业术语表
| 序号 | 英文原文 | 中文翻译 |
| 1 | Animal species used | 动物种属 |
| 2 | Animal model | 动物模型 |
| 3 | Absorption | 吸收 |
| 4 | Antigenicity | 抗原性 |
| 5 | Approximate lethal dose | 近似致死剂量 |
| 6 | Bioequivalence | 生物等效性 |
| 7 | Bioavailability | 生物利用度 |
| 8 | Carcinogenic risk | 致癌风险 |
| 9 | Carcinogenic potential | 潜在致癌性 |
| 10 | Carcinogenicity | 致癌性 |
| 11 | Dosages used | 给药剂量 |
| 12 | Duration of treatment or of the study | 给药持续时间 |
| 13 | Dose level | 给药剂量 |
| 14 | Duration of use | 给药持续时间 |
| 15 | Distribution | 分布 |
| 16 | Dependence | 依赖性 |
| 17 | Drug substance | 原料药 |
| 18 | Exposure in the test animals | 实验动物暴露量 |
| 19 | Exposure in human given | 人最大预期剂量下暴露量 |
| 20 | Excretion | 排泄 |
| 21 | Enzyme induction and inhibition | 酶诱导和抑制 |
| 22 | Excretion in milk | 乳汁排泄 |
| 23 | Excretion into bile | 胆汁排泄 |
| 24 | Embryo-fetal development | 胚胎-胎仔发育 |
| 25 | Fertility, embryofetal development, pre-and post-natal toxicity | 生育力、胚胎发育、围产期毒 性 |
| 26 | Fertility and early embryonic development to implantation | 生育力与早期胚胎发育 |
| 27 | Histopathology | 组织病理学 |
| 28 | Human dose | 人用剂量 |
| 29 | In vitro studies | 体外试验 |
| 30 | In vivo studies | 体内试验 |
| 31 | Intravenous injection | 静脉注射 |
| 32 | Intramuscular injection | 肌肉注射 |
| 33 | Intraperitoneal injection | 腹腔注射 |
| 34 | Inhalation | 吸入给药 |
| 35 | In vitro metabolism | 体外代谢 |
| 36 | Immunotoxicity | 免疫毒性 |
| 37 | Known genotoxic compounds | 已知遗传毒性化合物 |
| 38 | Kinetic parameters | 动力学参数 |
| 39 | Local tolerance | 局部耐受性 |
| 40 | Labeling | 说明书 |
| 41 | Local tolerance | 局部耐受性 |
| 42 | Long-term studies | 长期试验 |
| 43 | Metabolism | 代谢 |
| 44 | Mode of action | 作用方式 |
| 45 | Metabolites | 代谢物 |
| 46 | Metabolism | 代谢 |
| 47 | Maximum non-lethal dose | 最大非致死剂量 |
| 48 | Nonclinical overview and summaries | 非临床综述和总结 |
| 49 | Nonclinical testing strategy | 非临床试验策略 |
| 50 | Numbers of animals used | 动物数量 |
| 51 | No observed effect levels | 未见反应剂量 |
| 52 | No observed adverse effect levels | 未见不良反应剂量 |
| 53 | Non-human primate | 非人灵长类 |
| 54 | Non-mammals | 非哺乳动物 |
| 55 | Nonclinical models of disease | 非临床疾病模型 |
| 56 | Other non-rodent mammal | 其他非啮齿类哺乳动物 |
| 57 | Oral | 经口给药 |
| 58 | Organ distribution | 器官分布 |
| 59 | Pharmacology | 药理学 |
| 60 | Pharmacokinetics | 药代动力学 |
| 61 | Potential pharmacologic and toxicologic effects | 潜在药理和毒理反应 |
| 62 | Pharmacokinetic models | 药代动力学模型 |
| 63 | Potential adverse effects | 潜在不良反应 |
| 64 | Pathologic findings | 病理结果 |
| 65 | Pharmaceutical’s structure | 药物结构 |
| 66 | Pharmacologic properties | 药理学特性 |
| 67 | Proposed clinical indication | 申请的临床适应症 |
| 68 | Primary pharmacodynamics | 主要药效学 |
| 69 | Pharmacodynamic drug interactions | 药效学药物相互作用 |
| 70 | Pharmacokinetic drug interactions | 药代动力学药物相互作用 |
| 71 | Pharmacokinetic studies | 药代动力学试验 |
| 72 | Protein binding rate | 蛋白结合率 |
| 73 | Placental transfer studies | 胎盘转运试验 |
| 74 | Possible metabolic pathways | 可能的代谢途径 |
| 75 | Pre-systemic metabolism | 进入循环前的代谢 |
| 76 | Plasma protein binding | 血浆蛋白结合率 |
| 77 | Pivotal studies | 关键试验 |
| 78 | Routes of administration employed | 给药途径 |
| 79 | Routes and extent of excretion | 排泄途径和程度 |
| 80 | Repeat-dose toxicity | 重复给药毒性 |
| 81 | Reproductive and developmental toxicity | 生殖毒性 |
| 82 | Range-finding studies | 剂量探索试验 |
| 83 | Studies in juvenile animals | 幼龄动物试验 |
| 84 | Stereoisomers | 立体异构体 |
| 85 | Subcutaneous injection | 皮下注射 |
| 86 | Secondary pharmacodynamics | 次要药效学 |
| 87 | Safety pharmacology | 安全药理学 |
| 88 | Single-dose toxicity | 单次给药毒性 |
| 89 | Studies in juvenile animals | 幼龄动物试验 |
| 90 | Supportive toxicokinetics evaluations | 伴随毒代动力学试验 |
| 91 | Short- or medium-term studies | 短期或中期试验 |
| 92 | Studies on metabolites | 代谢产物研究 |
| 93 | Studies on impurities | 杂质研究 |
| 94 | Systemic exposures | 系统暴露量 |
| 95 | Toxicology | 毒理学 |
| 96 | Toxicokinetic data | 毒代动力学数据 |
| 97 | Toxic effects | 毒性反应 |
| 98 | Toxic signs | 毒性反应症状 |
| 99 | Toxic doses | 毒性剂量 |
| 100 | The maximum recommended | 人最大推荐剂量 |
| 101 | The maximum intended doses | 人最大预期剂量下暴露量 |
| 102 | The intended route for human use | 人拟用途径 |
| 103 | Topical | 局部给药 |
| 104 | Tissue distribution studies | 组织分布试验 |
| 105 | Whole-animal experiments | 整体动物试验 |
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