Bimosiamose

Module 1 Administrative information 模块 1 行政信息 1.1 Forms [Form Type (R)] 1.1 表格 [表格类型 (必选)] 1.2 Cover letters 1.2 附信 1.3 Administrative information 1.3 行政信息 1.3.1 Contact/sponsor/applicant information 1.3.1 联系人/申办方/申请人信息 1.3.1.1 Change of address or corporate name 1.3.1.1 地址或公司名称变更 1.3.1.2 Change in contact/agent 1.3.1.2 联系人/代理机构变更 1.3.1.3 Change in sponsor 1.3.1.3 申办方变更 1.3.1.4 Transfer of obligation 1.3.1.4 责任转让 1.3.1.5 Change in ownership of an application or reissuance of license 1.3.1.5 申请所有权变更或许可证重新颁发 1.3.2 Field copy certification 1.3.2 现场副本认证 1.3.3 Debarment certification 1.3.3 除名认证 1.3.4 Financial certification and disclosure 1.3.4 财务认证与披露 1.3.5 Patent and exclusivity 1.3.5 专利与独占权 1.3.5.1 Patent information 1.3.5.1 专利信息 1.3.5.2 Patent certification 1.3.5.2 专利认证 1.3.5.3 Exclusivity claim 1.3.5.3 独占权声明 1.3.6 Tropical disease priority review voucher 1.3.6 热带病优先审评券 1.4 References 1.4 参考文献 1.4.1 Letter of authorization 1.4.1 授权书 1.4.2 Statement of right of reference 1.4.2 引用权声明 1.4.3 List of authorized persons to incorporate by reference 1.4.3 授权通过引用纳入的人员名单 1.4.4 Cross- reference to previously submitted information 1.4.4 交叉引用先前提交的信息 1.5 Application status 1.5 申请状态 1.5.1 Withdrawal of an IND 1.5.1 IND的撤回 1.5.2 Inactivation request 1.5.2 失活申请 1.5.3 Reactivation request 1.5.3 再激活申请 1.5.4 Reinstatement request 1.5.4 恢复申请 1.5.5 Withdrawal of an unapproved BLA, NDA, ANDA, or Supplement 1.5.5 未批准的BLA、NDA、ANDA或补充申请的撤回 1.5.6 Withdrawal of listed drug 1.5.6 列入清单药物的撤回 1.5.7 Withdrawal of approval of an application or revocation of license 1.5.7 申请批准的撤销或许可证的吊销 1.6 Meetings 1.6 会议 1.6.1 Meeting request 1.6.1 会议申请 1.6.2 Meeting background materials 1.6.2 会议背景材料 1.6.3 Correspondence regarding meetings 1.6.3 关于会议的信函 1.7 Fast Track 1.7 快速通道 1.7.1 Fast track designation request 1.7.1 快速通道认定申请 1.7.2 Fast track designation withdrawal request 1.7.2 快速通道认定撤回申请 1.7.3 Rolling review request 1.7.3 滚动审评申请 1.7.4 Correspondence regarding fast track/rolling review 1.7.4 关于快速通道/滚动审评的信函 1.8 Special protocol assessment request 1.8 特殊方案评估申请 1.8.1 Clinical study 1.8.1 临床研究 1.8.2 Carcinogenicity study 1.8.2 致癌性研究 1.8.3 Stability study 1.8.3 稳定性研究 1.8.4 Animal efficacy study for approval under the animal rule 1.8.4 根据动物法规批准所需的动物有效性研究 1.9 Pediatric administrative information 1.9 儿科行政信息 1.9.1 Request for waiver of pediatric studies 1.9.1 儿科研究豁免申请 1.9.2 Request for deferral of pediatric studies 1.9.2 儿科研究推迟申请 1.9.3 Request for pediatric exclusivity determination 1.9.3 儿科独占权认定申请 1.9.4 Proposed pediatric study request and amendments 1.9.4 拟议儿科研究申请及修订 1.9.6 Other correspondence regarding pediatric exclusivity or study plans 1.9.6 关于儿科独占权或研究计划的其他信函 1.10 Dispute resolution 1.10 争议解决 1.10.1 Request for dispute resolution 1.10.1 争议解决申请 1.10.2 Correspondence related to dispute resolution 1.10.2 与争议解决相关的信函 1.11 Information amendment: Information not covered under modules 2 to 5 1.11 信息修订：模块2至5未涵盖的信息 1.11.1 Quality information amendment 1.11.1 质量信息修订 1.11.2 Nonclinical information amendment 1.11.2 非临床信息修订 1.11.3 Clinical information amendment 1.11.3 临床信息修订 1.11.4 Multiple module information amendment 1.11.4 多模块信息修订 1.12 Other correspondence 1.12 其他信函 1.12.1 Pre IND correspondence 1.12.1 IND前信函 1.12.2 Request to charge for clinical trial 1.12.2 临床试验收费申请 1.12.3 Request to charge for expanded access 1.12.3 扩大可及性收费申请 1.12.4 Request for comments and advice 1.12.4 征求意见和建议的申请 1.12.5 Request for a waiver 1.12.5 豁免申请 1.12.6 Exception from informed consent for emergency research 1.12.6 紧急研究知情同意例外 1.12.7 Public disclosure statement for exception from informed consent for emergency research 1.12.7 紧急研究知情同意例外的公开声明 1.12.8 Correspondence regarding exception from informed consent for emergency research 1.12.8 关于紧急研究知情同意例外的信函 1.12.9 Notification of discontinuation of clinical trial 1.12.9 临床试验终止通知 1.12.10 Generic drug enforcement act statement 1.12.10 仿制药执行法案声明 1.12.11 ANDA basis for submission statement 1.12.11 ANDA提交依据声明 1.12.12 Comparison of generic drug and reference listed drug 1.12.12 仿制药与参比制剂对比 1.12.13 Request for waiver for in vivo studies 1.12.13 体内研究豁免申请 1.12.14 Environmental analysis 1.12.14 环境分析 1.12.15 Request for waiver of in vivo bioavailability studies 1.12.15 体内生物利用度研究豁免申请 1.12.16 Field alert reports 1.12.16 现场警报报告 1.12.17 Orphan drug designation 1.12.17 孤儿药认定 1.12.18 Regenerative medicine advanced therapy (RMAT) designation 1.12.18 再生医学先进疗法认定 1.13 Annual report 1.13 年度报告 1.13.1 Summary for nonclinical studies 1.13.1 非临床研究总结 1.13.2 Summary of clinical pharmacology information 1.13.2 临床药理学信息总结 1.13.3 Summary of safety information 1.13.3 安全性信息总结 1.13.4 Summary of labeling changes 1.13.4 说明书变更总结 1.13.5 Summary of manufacturing changes 1.13.5 生产变更总结 1.13.6 Summary of microbiological changes 1.13.6 微生物学变更总结 1.13.7 Summary of other significant new information 1.13.7 其他重要新信息总结 1.13.8 Individual study information 1.13.8 单项研究信息 1.13.9 General investigational plan 1.13.9 总体研究计划 1.13.10 Foreign marketing 1.13.10 国外上市情况 1.13.11 Distribution data 1.13.11 分销数据 1.13.12 Status of postmarketing study commitments and requirements 1.13.12 上市后研究承诺和要求的状态 1.13.13 Status of other postmarketing studies and requirements 1.13.13 其他上市后研究和要求的状态 1.13.14 Log of outstanding regulatory business 1.13.14 未决监管事项日志 1.13.15 Development safety update report (DSUR) 1.13.15 研发安全性更新报告 1.14 Labeling 1.14 说明书与标签 1.14.1 Draft labeling 1.14.1 草案说明书与标签 1.14.1.1 Draft carton and container labels 1.14.1.1 草案外盒和容器标签 1.14.1.2 Annotated draft labeling text 1.14.1.2 带注释的草案说明书文本 1.14.1.3 Draft labeling text 1.14.1.3 草案说明书文本 1.14.1.4 Label comprehension studies 1.14.1.4 标签理解研究 1.14.1.5 Labeling history 1.14.1.5 说明书标签历史 1.14.2 Final labeling 1.14.2 最终说明书与标签 1.14.2.1 Final carton or container labels 1.14.2.1 最终外盒或容器标签 1.14.2.2 Final package insert (package inserts, patient information, medication guides) 1.14.2.2 最终药品说明书（包装说明书、患者信息、用药指南） 1.14.2.3 Final labeling text 1.14.2.3 最终说明书文本 1.14.3 Listed drug labeling 1.14.3 列入清单药物的说明书与标签 1.14.3.1 Annotated comparison with listed drug 1.14.3.1 与列入清单药物的带注释对比 1.14.3.2 Approved labeling text for listed drug 1.14.3.2 列入清单药物的已批准说明书文本 1.14.3.3 Labeling text for reference listed drug 1.14.3.3 参比制剂的说明书文本 1.14.4 Investigational drug labeling 1.14.4 试验用药品的说明书与标签 1.14.4.1 Investigational brochure 1.14.4.1 研究者手册 1.14.4.2 Investigational drug labeling 1.14.4.2 试验用药品标签说明书 1.14.5 Foreign labeling 1.14.5 国外说明书与标签 1.14.6 Product labeling for 2253 submissions 1.14.6 用于2253提交的产品说明书标签 1.15 Promotional material [promotional- material- audience- type (R)] 1.15 促销材料 [促销材料受众类型 (必选)] 1.15.1 Correspondence relating to promotional materials 1.15.1 关于促销材料的信函 1.15.1.1 Request for advisory comments on launch materials 1.15.1.1 关于上市材料的咨询意见请求 1.15.1.2 Request for advisory comments on non- launch materials 1.15.1.2 关于非上市材料的咨询意见请求 1.15.1.3 Presubmission of launch promotional materials for accelerated approval products 1.15.1.3 加速批准产品的上市促销材料的预提交 1.15.1.4 Presubmission of non- launch promotional materials for accelerated approval products 1.15.1.4 加速批准产品的非上市促销材料的预提交 1.15.1.5 Pre- dissemination review of television ads 1.15.1.5 电视广告的传播前审查 1.15.1.6 Response to untitled letter or warning letter 1.15.1.6 对无标题信函或警告信函的回复 1.15.1.7 Response to information request 1.15.1.7 对信息请求的回复 1.15.1.8 Correspondence accompanying materials previously missing or rejected 1.15.1.8 伴随先前缺失或拒绝材料的信函 1.15.1.9 Withdrawal request 1.15.1.9 撤回申请 1.15.1.10 Submission of annotated references 1.15.1.10 提交带注释的参考文献 1.15.1.11 General correspondence 1.15.1.11 一般信函 1.15.2 Materials [promotional- material- doc- type (R)] 1.15.2 材料 [促销材料文档类型 (必选)] 1.15.2.1 Material [promotional- material- type (R), material- id (R), issue- date(O)] 1.15.2.1 材料 [促销材料类型 (必选), 材料ID (必选), 发行日期 (可选)] 1.15.2.1.1 Clean version 1.15.2.1.1 清洁版本 1.15.2.1.2 Annotated version 1.15.2.1.2 带注释版本 1.15.2.1.3 Annotated labeling version 1.15.2.1.3 带注释的标签版本 1.15.2.1.4 Annotated references 1.15.2.1.4 带注释的参考文献 1.16 Risk management plan 1.16 风险管理计划 1.16.1 Risk Management (Non- REMS) 1.16.1 风险管理（非REMS） 1.16.2 Risk Evaluation and Mitigation Strategy (REMS) 1.16.2 风险评估与减轻策略 1.16.2.1 Final REMS 1.16.2.1 最终REMS 1.16.2.2 Draft REMS 1.16.2.2 草案REMS 1.16.2.3 REMS Assessment 1.16.2.3 REMS评估 1.16.2.4 REMS Assessment Methodology 1.16.2.4 REMS评估方法 1.16.2.5 REMS Correspondence 1.16.2.5 REMS信函 1.16.2.6 REMS Modification History 1.16.2.6 REMS修订历史 1.17 Postmarketing studies 1.17 上市后研究 1.17.1 Correspondence regarding postmarketing commitments 1.17.1 关于上市后承诺的信函 1.17.2 Correspondence regarding postmarketing requirements 1.17.2 关于上市后要求的信函 1.18 Naming 1.18 命名 1.18.1 Proprietary names 1.18.1 专有名称 1.18.2 Biological Proper Name Suffix 1.18.2 生物制品通用名称后缀 1.19 Pre- EUA and EUA 1.19 紧急使用授权前和紧急使用授权 1.20 General investigational plan for initial IND 1.20 首次IND的总体研究计划 Module 2 Summaries 模块 2 总结 2.2 Introduction to summary 2.2 总结引言 2.3 Quality overall summary 2.3 质量总体总结 2.3.1 Introduction 2.3.1 引言 2.3.S Drug substance [substance (O), manufacturer (O)] 2.3.S 原料药 [物质 (可选), 生产商 (可选)] 2.3.P Drug product [product (O), dosage form (O)] 2.3.P 制剂 [产品 (可选), 剂型 (可选)] 2.3.A Appendices 2.3.A 附录 2.3.A.1 Facilities and equipment [facility (O)] 2.3.A.1 设施与设备 [设施 (可选)] 2.3.A.2 Adventitious agents safety evaluation [component (O)] 2.3.A.2 外源因子安全性评估 [成分 (可选)] 2.3.A.3 Excipients 2.3.A.3 辅料 2.3.R Regional information 2.3.R 地区信息 2.4 Nonclinical overview 2.4 非临床概述 2.5 Clinical overview 2.5 临床概述 2.6 Nonclinical written and tabulated summaries 2.6 非临床书面与表格总结 2.6.1 Introduction 2.6.1 引言 2.6.2 Pharmacology written summary 2.6.2 药理学书面总结 2.6.3 Pharmacology tabulated summary 2.6.3 药理学表格总结 2.6.4 Pharmacokinetic written summary 2.6.4 药代动力学书面总结 2.6.5 Pharmacokinetic tabulated summary 2.6.5 药代动力学表格总结 2.6.6 Toxicology written summary 2.6.6 毒理学书面总结 2.6.7 Toxicology tabulated summary 2.6.7 毒理学表格总结 2.7 Clinical summary 2.7 临床总结 2.7.1 Summary of Biopharmaceutical Studies and Associated Analytical Methods 2.7.1 生物药剂学研究及相关分析方法总结 2.7.2 Summary of Clinical Pharmacology studies 2.7.2 临床药理学研究总结 2.7.3 Summary of Clinical Efficacy [indication (R)] 2.7.3 临床有效性总结 [适应症 (必选)] 2.7.4 Summary of Clinical Safety 2.7.4 临床安全性总结 2.7.5 References 2.7.5 参考文献 2.7.6 Synopses of individual studies 2.7.6 单项研究摘要 Module 3 Quality 模块 3 质量 3.2 Body of data 3.2 数据主体 3.2.S Drug substance [substance (O), manufacturer (O)] 3.2.S 原料药 [物质 (可选), 生产商 (可选)] 3.2.S.1 General information 3.2.S.1 基本信息 3.2.S.2 Manufacture 3.2.S.2 生产 3.2.S.2.1 Manufacturer(s) 3.2.S.2.1 生产商 3.2.S.2.2 Description of Manufacturing Process and Process Controls 3.2.S.2.2 生产工艺与过程控制描述 3.2.S.2.3 Control of Materials 3.2.S.2.3 物料控制 3.2.S.2.4 Controls of Critical Steps and Intermediates 3.2.S.2.4 关键步骤与中间体控制 3.2.S.2.5 Process Validation and/or Evaluation 3.2.S.2.5 工艺验证和/或评估 3.2.S.2.6 Manufacturing Process Development 3.2.S.2.6 生产工艺开发 3.2.S.3 Characterization 3.2.S.3 表征 3.2.S.3.1 Elucidation of Structure and other Characteristics 3.2.S.3.1 结构确证及其他特性 3.2.S.3.2 Impurities 3.2.S.3.2 杂质 3.2.S.4 Control of drug substance 3.2.S.4 原料药控制 3.2.S.4.1 Specification 3.2.S.4.1 质量标准 3.2.S.4.2 Analytical Procedures 3.2.S.4.2 分析规程 3.2.S.4.3 Validation of Analytical Procedures 3.2.S.4.3 分析规程验证 3.2.S.4.4 Batch Analyses 3.2.S.4.4 批分析 3.2.S.4.5 Justification of Specification 3.2.S.4.5 质量标准论证 3.2.S.5 Reference standards or materials 3.2.S.5 对照品或标准物质 3.2.S.6 Container closure systems 3.2.S.6 容器密封系统 3.2.S.7 Stability 3.2.S.7 稳定性 3.2.S.7.1 Stability Summary and Conclusions 3.2.S.7.1 稳定性总结与结论 3.2.S.7.2 Post Approval Stability Protocol and Stability Commitment 3.2.S.7.2 批准后稳定性方案与稳定性承诺 3.2.S.7.3 Stability Data [descriptor (O)] 3.2.S.7.3 稳定性数据 [描述符 (可选)] 3.2.P Drug product [product (O), dosage form (O), manufacturer (O)] 3.2.P 制剂 [产品 (可选), 剂型 (可选), 生产商 (可选)] 3.2.P.1 Description and composition of the drug product 3.2.P.1 制剂描述与组成 3.2.P.2 Pharmaceutical development 3.2.P.2 药学开发 3.2.P.2.1 Components of the Drug Product 3.2.P.2.1 制剂组分 3.2.P.2.2 Drug Product 3.2.P.2.2 制剂 3.2.P.2.3 Manufacturing Process Development 3.2.P.2.3 生产工艺开发 3.2.P.2.4 Container Closure System 3.2.P.2.4 容器密封系统 3.2.P.2.5 Microbiological Attributes 3.2.P.2.5 微生物学属性 3.2.P.2.6 Compatibility 3.2.P.2.6 相容性 3.2.P.3 Manufacture 3.2.P.3 生产 3.2.P.3.1 Manufacturer(s) 3.2.P.3.1 生产商 3.2.P.3.2 Batch Formula 3.2.P.3.2 批处方 3.2.P.3.3 Description of Manufacturing Process and Process Controls 3.2.P.3.3 生产工艺与过程控制描述 3.2.P.3.4 Controls of Critical Steps and Intermediates 3.2.P.3.4 关键步骤与中间体控制 3.2.P.3.5 Process Validation and/or Evaluation 3.2.P.3.5 工艺验证和/或评估 3.2.P.4 Control of excipients [excipient (O)] 3.2.P.4 辅料控制 [辅料 (可选)] 3.2.P.4.1 Specification(s) 3.2.P.4.1 质量标准 3.2.P.4.2 Analytical Procedures 3.2.P.4.2 分析规程 3.2.P.4.3 Validation of Analytical Procedures 3.2.P.4.3 分析规程验证 3.2.P.4.4 Justification of Specifications 3.2.P.4.4 质量标准论证 3.2.P.4.5 Excipients of Human or Animal Origin 3.2.P.4.5 人或动物源辅料 3.2.P.4.6 Novel Excipients 3.2.P.4.6 新型辅料 3.2.P.5 Control of drug product 3.2.P.5 制剂控制 3.2.P.5.1 Specification(s) 3.2.P.5.1 质量标准 3.2.P.5.2 Analytical Procedures 3.2.P.5.2 分析规程 3.2.P.5.3 Validation of Analytical Procedures 3.2.P.5.3 分析规程验证 3.2.P.5.4 Batch Analyses 3.2.P.5.4 批分析 3.2.P.5.5 Characterization of Impurities 3.2.P.5.5 杂质表征 3.2.P.5.6 Justification of Specification(s) 3.2.P.5.6 质量标准论证 3.2.P.6 Reference standards or materials 3.2.P.6 对照品或标准物质 3.2.P.7 Container closure system [container (O)] 3.2.P.7 容器密封系统 [容器 (可选)] 3.2.P.8 Stability 3.2.P.8 稳定性 3.2.P.8.1 Stability Summary and Conclusion 3.2.P.8.1 稳定性总结与结论 3.2.P.8.2 Postapproval Stability Protocol and Stability Commitment 3.2.P.8.2 批准后稳定性方案与稳定性承诺 3.2.P.8.3 Stability Data [descriptor (O)] 3.2.P.8.3 稳定性数据 [描述符 (可选)] 3.2.A Appendices 3.2.A 附录 3.2.A.1 Facilities and Equipment [facility (O)] 3.2.A.1 设施与设备 [设施 (可选)] 3.2.A.2 Adventitious agents safety evaluation [component (O)] 3.2.A.2 外源因子安全性评估 [成分 (可选)] 3.2.A.3 Novel excipients [excipient (O)] 3.2.A.3 新型辅料 [辅料 (可选)] 3.2.R Regional information 3.2.R 地区信息 3.3 Literature references 3.3 参考文献 Module 4 Nonclinical Study Reports 模块 4 非临床研究报告 4.2 Study reports 4.2 研究报告 4.2.1 Pharmacology 4.2.1 药理学 4.2.1.1 Primary pharmacodynamics [study id_study title (R)] [document type (R)] 4.2.1.1 主要药效学 [研究ID_研究标题 (必选)] [文档类型 (必选)] Legacy clinical study report 遗留临床研究报告 Pre clinical study report 临床前研究报告 Synopsis 摘要 Study report body 研究报告正文 Protocol or amendment 方案或修订案 Signatures investigators 研究者签名 Audit certificates report 审计证书报告 Statistical methods interim analysis plan 统计方法中期分析计划 Inter-laboratory standardisation methods quality assurance 实验室间标准化方法质量保证 Publications based on study 基于研究的出版物 Publications referenced in report 报告中引用的出版物 Compliance and drug concentration data 依从性与药物浓度数据 Data tabulation 数据列表 Data tabulation dataset legacy 数据列表数据集（遗留格式） Data tabulation dataset send 数据列表数据集 (SEND) Data tabulation data definition 数据列表数据定义 Data listing data set 数据列表数据集 Data listing dataset 数据列表数据集 Data listing data definition 数据列表数据定义 Analysis datasets 分析数据集 Analysis dataset adam 分析数据集 (ADaM) Analysis dataset legacy 分析数据集（遗留格式） Analysis program 分析程序 Analysis data definition 分析数据定义 Safety report 安全性报告 Assay validation 分析方法验证 Biomarkers 生物标志物 Data monitoring review committees 数据监查委员会 Device information 器械信息 Diagnostic tests 诊断试验 Gene therapy 基因治疗 Pharmacodynamics 药效学 Pharmacogenomics 药物基因组学 Pharmacokinetics 药代动力学 Stem cells 干细胞 Antibody 抗体 Other data not specified 其他未明确数据 PK/PD relationship PK/PD 关系 Specialty report 专业报告 Foreign clinical studies not under ind 非 IND 下的国外临床研究 PD InVivo Study 体内药效学研究 PD InVitro Study 体外药效学研究 QT InVitro Study 体外 QT 研究 Study data reviewer’s guide 研究数据审评指南 Weight of evidence 证据权重 Animal rule efficacy 动物法规有效性 Animal rule natural history 动物法规自然史 Nonstandard safety study 非标准安全性研究 4.2.1.2 Secondary pharmacodynamics [study id_study title (R)] [document type (R)] 4.2.1.2 次要药效学 [研究ID_研究标题 (必选)] [文档类型 (必选)] (See Primary pharmacodynamics above for available document types) (可用文档类型参见上文主要药效学) 4.2.1.3 Safety pharmacology [study id_study title (R)] [document type (R)] 4.2.1.3 安全药理学 [研究ID_研究标题 (必选)] [文档类型 (必选)] (See Primary pharmacodynamics above for available document types) (可用文档类型参见上文主要药效学) 4.2.1.4 Pharmacodynamic drug interactions [study id_study title (R)] [document type (R)] 4.2.1.4 药效学药物相互作用 [研究ID_研究标题 (必选)] [文档类型 (必选)] (See Primary pharmacodynamics above for available document types) (可用文档类型参见上文主要药效学) 4.2.2 Pharmacokinetics 4.2.2 药代动力学 4.2.2.1 Analytical methods and validation reports [study id_study title (R)] [document type (R)] 4.2.2.1 分析方法与验证报告 [研究ID_研究标题 (必选)] [文档类型 (必选)] (See Primary pharmacodynamics above for available document types) (可用文档类型参见上文主要药效学) 4.2.2.2 Absorption [study id_study title (R)] [document type (R)] 4.2.2.2 吸收 [研究ID_研究标题 (必选)] [文档类型 (必选)] (See Primary pharmacodynamics above for available document types) (可用文档类型参见上文主要药效学) 4.2.2.3 Distribution [study id_study title (R)] [document type (R)] 4.2.2.3 分布 [研究ID_研究标题 (必选)] [文档类型 (必选)] (See Primary pharmacodynamics above for available document types) (可用文档类型参见上文主要药效学) 4.2.2.4 Metabolism [study id_study title (R)] [document type (R)] 4.2.2.4 代谢 [研究ID_研究标题 (必选)] [文档类型 (必选)] (See Primary pharmacodynamics above for available document types) (可用文档类型参见上文主要药效学) 4.2.2.5 Excretion [study id_study title (R)] [document type (R)] 4.2.2.5 排泄 [研究ID_研究标题 (必选)] [文档类型 (必选)] (See Primary pharmacodynamics above for available document types) (可用文档类型参见上文主要药效学) 4.2.2.6 Pharmacokinetic drug interactions [study id_study title (R)] [document type (R)] 4.2.2.6 药代动力学药物相互作用 [研究ID_研究标题 (必选)] [文档类型 (必选)] (See Primary pharmacodynamics above for available document types) (可用文档类型参见上文主要药效学) 4.2.2.7 Other pharmacokinetic studies [study id_study title (R)] [document type (R)] 4.2.2.7 其他药代动力学研究 [研究ID_研究标题 (必选)] [文档类型 (必选)] (See Primary pharmacodynamics above for available document types) (可用文档类型参见上文主要药效学) 4.2.3 Toxicology 4.2.3 毒理学 4.2.3.1 Single dose toxicity [study id_study title (R) species (R), route of admin (R)] [document type (R)] 4.2.3.1 单剂量毒性 [研究ID_研究标题 (必选), 种属 (必选), 给药途径 (必选)] [文档类型 (必选)] (See Primary pharmacodynamics above for available document types) (可用文档类型参见上文主要药效学) 4.2.3.2 Repeat dose toxicity [study id_study title (R) species (R), route of admin (R), duration(O)] [document type (R)] 4.2.3.2 重复剂量毒性 [研究ID_研究标题 (必选), 种属 (必选), 给药途径 (必选), 周期 (可选)] [文档类型 (必选)] (See Primary pharmacodynamics above for available document types) (可用文档类型参见上文主要药效学) 4.2.3.3 Genotoxicity 4.2.3.3 遗传毒性 4.2.3.3.1 In vitro [study id_study title (R)] [document type (R)] 4.2.3.3.1 体外 [研究ID_研究标题 (必选)] [文档类型 (必选)] (See Primary pharmacodynamics above for available document types) (可用文档类型参见上文主要药效学) 4.2.3.3.2 In vivo [study id_study title (R)] [document type (R)] 4.2.3.3.2 体内 [研究ID_研究标题 (必选)] [文档类型 (必选)] (See Primary pharmacodynamics above for available document types) (可用文档类型参见上文主要药效学) 4.2.3.4 Carcinogenicity 4.2.3.4 致癌性 4.2.3.4.1 Long term studies [study id_study title (R), species (R)] [document type (R)] 4.2.3.4.1 长期研究 [研究ID_研究标题 (必选), 种属 (必选)] [文档类型 (必选)] (See Primary pharmacodynamics above for available document types) (可用文档类型参见上文主要药效学) 4.2.3.4.2 Short or medium term studies [study id_study title (R)] [document type (R)] 4.2.3.4.2 短期或中期研究 [研究ID_研究标题 (必选)] [文档类型 (必选)] (See Primary pharmacodynamics above for available document types) (可用文档类型参见上文主要药效学) 4.2.3.4.3 Other studies [study id_study title (R)] [document type (R)] 4.2.3.4.3 其他研究 [研究ID_研究标题 (必选)] [文档类型 (必选)] (See Primary pharmacodynamics above for available document types) (可用文档类型参见上文主要药效学) 4.2.3.5 Reproductive and developmental toxicity 4.2.3.5 生殖与发育毒性 4.2.3.5.1 Fertility and early embryonic development [study id_study title (R)] [document type (R)] 4.2.3.5.1 生育力与早期胚胎发育 [研究ID_研究标题 (必选)] [文档类型 (必选)] (See Primary pharmacodynamics above for available document types) (可用文档类型参见上文主要药效学) 4.2.3.5.2 Embryofetal development [study id_study title (R)] [document type (R)] 4.2.3.5.2 胚胎-胎仔发育 [研究ID_研究标题 (必选)] [文档类型 (必选)] (See Primary pharmacodynamics above for available document types) (可用文档类型参见上文主要药效学) 4.2.3.5.3 Prenatal and postnatal development, including maternal function [study id_study title (R)] [document type (R)] 4.2.3.5.3 围产期发育，包括母体功能 [研究ID_研究标题 (必选)] [文档类型 (必选)] (See Primary pharmacodynamics above for available document types) (可用文档类型参见上文主要药效学) 4.2.3.5.4 Studies in which the offspring (juvenile animals) are dosed and/or further evaluated [study id_study title (R)] [document type (R)] 4.2.3.5.4 子代（幼年动物）给药和/或进一步评估的研究 [研究ID_研究标题 (必选)] [文档类型 (必选)] (See Primary pharmacodynamics above for available document types) (可用文档类型参见上文主要药效学) 4.2.3.6 Local tolerance [study id_study title (R)] [document type (R)] 4.2.3.6 局部耐受性 [研究ID_研究标题 (必选)] [文档类型 (必选)] (See Primary pharmacodynamics above for available document types) (可用文档类型参见上文主要药效学) 4.2.3.7 Other toxicity studies 4.2.3.7 其他毒性研究 4.2.3.7.1 Antigenicity [study id_study title (R)] [document type (R)] 4.2.3.7.1 抗原性 [研究ID_研究标题 (必选)] [文档类型 (必选)] (See Primary pharmacodynamics above for available document types) (可用文档类型参见上文主要药效学) 4.2.3.7.2 Immunotoxicity [study id_study title (R)] [document type (R)] 4.2.3.7.2 免疫毒性 [研究ID_研究标题 (必选)] [文档类型 (必选)] (See Primary pharmacodynamics above for available document types) (可用文档类型参见上文主要药效学) 4.2.3.7.3 Mechanistic studies [study id_study title (R)] [document type (R)] 4.2.3.7.3 机制研究 [研究ID_研究标题 (必选)] [文档类型 (必选)] (See Primary pharmacodynamics above for available document types) (可用文档类型参见上文主要药效学) 4.2.3.7.4 Dependence [study id_study title (R)] [document type (R)] 4.2.3.7.4 依赖性 [研究ID_研究标题 (必选)] [文档类型 (必选)] (See Primary pharmacodynamics above for available document types) (可用文档类型参见上文主要药效学) 4.2.3.7.5 Metabolites [study id_study title (R)] [document type (R)] 4.2.3.7.5 代谢产物 [研究ID_研究标题 (必选)] [文档类型 (必选)] (See Primary pharmacodynamics above for available document types) (可用文档类型参见上文主要药效学) 4.2.3.7.6 Impurities [study id_study title (R)] [document type (R)] 4.2.3.7.6 杂质 [研究ID_研究标题 (必选)] [文档类型 (必选)] (See Primary pharmacodynamics above for available document types) (可用文档类型参见上文主要药效学) 4.2.3.7.7 Other [study id_study title (R)] [document type (R)] 4.2.3.7.7 其他 [研究ID_研究标题 (必选)] [文档类型 (必选)] (See Primary pharmacodynamics above for available document types) (可用文档类型参见上文主要药效学) 4.3 Literature references 4.3 参考文献 Module 5 Clinical Study Reports 模块 5 临床研究报告 5.2 Tabular listing of all clinical studies 5.2 所有临床研究的表格列表 5.3 Clinical study reports and related information 5.3 临床研究报告及相关信息 5.3.1 Reports of biopharmaceutical studies 5.3.1 生物药剂学研究报告 5.3.1.1 Bioavailability (BA) Study reports and related information [study id_ study title (R)] [document type (R)] 5.3.1.1 生物利用度研究及相关信息报告 [研究ID_研究标题 (必选)] [文档类型 (必选)] Legacy clinical study report 遗留临床研究报告 Synopsis (ICH E3, section 2) 摘要 (ICH E3, 第2部分) Study report body (E3 1, 3 to 15) 研究报告正文 (E3 1, 3至15部分) Protocol or amendment (E3 16.1.1) 方案或修订案 (E3 16.1.1) Sample case report form (E3 16.1.2) 病例报告表模板 (E3 16.1.2) IEC- IRB consent form list (E3 16.1.3) IEC-IRB 知情同意书列表 (E3 16.1.3) List description investigator site (E3 16.1.4) 研究者中心列表描述 (E3 16.1.4) Signatures investigators (E3 16.1.5) 研究者签名 (E3 16.1.5) List patients with batches (E3 16.1.6) 患者与批次列表 (E3 16.1.6) Randomisation scheme (E3 16.1.7) 随机化方案 (E3 16.1.7) Audit certificates report (E3 16.1.8) 审计证书报告 (E3 16.1.8) Statistical methods interim analysis plan (E3 16.1.9) 统计方法中期分析计划 (E3 16.1.9) Inter- laboratory standardisation methods quality assurance (E3 16.1.10) 实验室间标准化方法质量保证 (E3 16.1.10) Publications based on study (E3 16.1.11) 基于研究的出版物 (E3 16.1.11) Publications referenced in report (E3 16.1.12) 报告中引用的出版物 (E3 16.1.12) Discontinued patients (E3 16.2.1) 中止患者 (E3 16.2.1) Protocol deviations (E3 16.2.2) 方案偏离 (E3 16.2.2) Patients excluded from efficacy analysis (E3 16.2.3) 从有效性分析中排除的患者 (E3 16.2.3) Demographic data (E3 16.2.4) 人口学数据 (E3 16.2.4) Compliance and drug concentration data (E3 16.2.5) 依从性与药物浓度数据 (E3 16.2.5) Individual efficacy response data (E3 16.2.6) 个体有效性反应数据 (E3 16.2.6) Adverse event listings (E3 16.2.7) 不良事件列表 (E3 16.2.7) Listing individual laboratory measurements by patient (E3 16.2.8) 按患者列出的个体实验室测量值列表 (E3 16.2.8) Case report forms (E3 16.3) 病例报告表 (E3 16.3) Site [site- id (O)] 中心 [中心ID (可选)] CSR 临床研究报告 Other 其他 Available on request 可根据要求提供 Data tabulation 数据列表 Data tabulation dataset legacy 数据列表数据集（遗留格式） Data tabulation dataset sdtm 数据列表数据集 (SDTM) Data tabulation data definition 数据列表数据定义 Data listing dataset (E3 16.4) 数据列表数据集 (E3 16.4) Data listing dataset 数据列表数据集 Data listing data definition 数据列表数据定义 Analysis datasets 分析数据集 Analysis dataset adam 分析数据集 (ADaM) Analysis dataset legacy 分析数据集（遗留格式） Analysis program 分析程序 Analysis data definition 分析数据定义 Annotated CRF 带注释的病例报告表 ECG 心电图 Image 图像 Subject profiles 受试者概况 Site [site-id (O)] 研究中心 [中心ID (可选)] Safety report 安全性报告 Assay validation 分析方法验证 Biomarkers 生物标志物 Data monitoring review committees 数据监查委员会 Device information 器械信息 Diagnostic tests 诊断试验 Gene therapy 基因治疗 Patient reported outcomes 患者报告结局 Pharmacodynamics 药效学 Pharmacogenomics 药物基因组学 Pharmacokinetics 药代动力学 Quality of life 生活质量 Hepatic Impairment Study 肝功能不全研究 Renal Impairment Study 肾功能不全研究 Drug-drug Interaction Study 药物相互作用研究 Mass Balance Study 物质平衡研究 Population PK Report 群体药代动力学报告 Population PKPD Report 群体药代动力学/药效学报告 PBPK Report 生理药代动力学报告 PBBM Report 生理生物药剂学模型报告 QSP Report 定量系统药理学报告 CP General 临床药理学通用 QT Clinical Study QT临床研究 Stem cells 干细胞 Abuse liability 滥用倾向 Antibody 抗体 Healthcare utilization 医疗资源利用 Other data not specified 其他未明确数据 PK/PD relationship PK/PD关系 Specialty report 专业报告 Foreign clinical studies not under ind 非IND下的国外临床研究 Study data reviewer’s guide 研究数据审评指南 Analysis data reviewer’s guide 分析数据审评指南 5.3.1.2 Comparative BA and bioequivalence (BE) Study reports and related information [study id_study title (R)] [document type (R)] 5.3.1.2 比较性BA和生物等效性研究及相关信息报告 [研究ID_研究标题 (必选)] [文档类型 (必选)] (See Bioavailability (BA) Study reports and related information above for available document types) (可用文档类型参见上文生物利用度研究报告及相关信息) 5.3.1.3 In Vitro - in Vivo correlation Study reports and related information [study id_study title (R)] [document type (R)] 5.3.1.3 体外-体内相关性研究报告及相关信息 [研究ID_研究标题 (必选)] [文档类型 (必选)] (See Bioavailability (BA) Study reports and related information above for available document types) (可用文档类型参见上文生物利用度研究报告及相关信息) 5.3.1.4 Reports of bioanalytical and analytical methods for human studies [study id_study title (R)] [document type (R)] 5.3.1.4 人体研究的生物分析与分析方法报告 [研究ID_研究标题 (必选)] [文档类型 (必选)] (See Bioavailability (BA) Study reports and related information above for available document types) (可用文档类型参见上文生物利用度研究报告及相关信息) 5.3.2 Reports of studies pertinent to pharmacokinetics using human biomaterials 5.3.2 使用人体生物材料的药代动力学相关研究报告 5.3.2.1 Plasma protein binding Study reports and related information [study id_study title (R)] [document type (R)] 5.3.2.1 血浆蛋白结合研究报告及相关信息 [研究ID_研究标题 (必选)] [文档类型 (必选)] (See Bioavailability (BA) Study reports and related information above for available document types) (可用文档类型参见上文生物利用度研究报告及相关信息) 5.3.2.2 Reports of hepatic metabolism and drug interaction studies [study id_study title (R)] [document type (R)] 5.3.2.2 肝脏代谢与药物相互作用研究报告 [研究ID_研究标题 (必选)] [文档类型 (必选)] (See Bioavailability (BA) Study reports and related information above for available document types) (可用文档类型参见上文生物利用度研究报告及相关信息) 5.3.2.3 Reports of studies using other human biomaterials [study id_study title (R)] [document type (R)] 5.3.2.3 使用其他人源生物材料的研究报告 [研究ID_研究标题 (必选)] [文档类型 (必选)] (See Bioavailability (BA) Study reports and related information above for available document types) (可用文档类型参见上文生物利用度研究报告及相关信息) 5.3.3 Reports of human pharmacokinetic (PK) studies 5.3.3 人体药代动力学研究报告 5.3.3.1 Healthy subject PK and initial tolerability Study reports and related information [study id_study title (R)] [document type (R)] 5.3.3.1 健康受试者PK与初始耐受性研究报告及相关信息 [研究ID_研究标题 (必选)] [文档类型 (必选)] (See Bioavailability (BA) Study reports and related information above for available document types) (可用文档类型参见上文生物利用度研究报告及相关信息) 5.3.3.2 Patient PK and initial tolerability Study reports and related information [study id_study title (R)] [document type (R)] 5.3.3.2 患者PK与初始耐受性研究报告及相关信息 [研究ID_研究标题 (必选)] [文档类型 (必选)] (See Bioavailability (BA) Study reports and related information above for available document types) (可用文档类型参见上文生物利用度研究报告及相关信息) 5.3.3.3 Intrinsic factor PK Study reports and related information [study id_study title (R)] [document type (R)] 5.3.3.3 内在因素PK研究报告及相关信息 [研究ID_研究标题 (必选)] [文档类型 (必选)] (See Bioavailability (BA) Study reports and related information above for available document types) (可用文档类型参见上文生物利用度研究报告及相关信息) 5.3.3.4 Extrinsic factor Study reports and related information [study id_study title (R)] [document type (R)] 5.3.3.4 外在因素研究报告及相关信息 [研究ID_研究标题 (必选)] [文档类型 (必选)] (See Bioavailability (BA) Study reports and related information above for available document types) (可用文档类型参见上文生物利用度研究报告及相关信息) 5.3.3.5 Population PK Study reports and related information [study id_study title (R)] [document type (R)] 5.3.3.5 群体PK研究报告及相关信息 [研究ID_研究标题 (必选)] [文档类型 (必选)] (See Bioavailability (BA) Study reports and related information above for available document types) (可用文档类型参见上文生物利用度研究报告及相关信息) 5.3.4 Reports of human pharmacodynamic (PD) studies 5.3.4 人体药效学研究报告 5.3.4.1 Healthy subject PD and PK/PD Study reports and related information [study id_ study title (R)] [document type (R)] 5.3.4.1 健康受试者PD和PK/PD研究报告及相关信息 [研究ID_研究标题 (必选)] [文档类型 (必选)] (See Bioavailability (BA) Study reports and related information above for available document types) (可用文档类型参见上文生物利用度研究报告及相关信息) 5.3.4.2 Patient PD and PK/PD Study reports and related information [study id_ study title (R)] [document type (R)] 5.3.4.2 患者PD和PK/PD研究报告及相关信息 [研究ID_研究标题 (必选)] [文档类型 (必选)] (See Bioavailability (BA) Study reports and related information above for available document types) (可用文档类型参见上文生物利用度研究报告及相关信息) 5.3.5 Reports of efficacy and safety studies [indication (R)] 5.3.5 有效性与安全性研究报告 [适应症 (必选)] 5.3.5.1 Study reports and related information of controlled clinical studies pertinent to the claimed indication [study id_ study title (R), type of control (R)] [document type (R)] 5.3.5.1 与声称适应症相关的对照临床研究的研究报告及相关信息 [研究ID_研究标题 (必选), 对照类型 (必选)] [文档类型 (必选)] (See Bioavailability (BA) Study reports and related information above for available document types) (可用文档类型参见上文生物利用度研究报告及相关信息) 5.3.5.2 Study reports and related information of uncontrolled clinical studies [study id_ study title (R)] [document type (R)] 5.3.5.2 非对照临床研究的研究报告及相关信息 [研究ID_研究标题 (必选)] [文档类型 (必选)] (See Bioavailability (BA) Study reports and related information above for available document types) (可用文档类型参见上文生物利用度研究报告及相关信息) 5.3.5.3 Reports of analyses of data from more than one study [study id_ study title (R)] [document type (R)] 5.3.5.3 多项研究数据综合分析报告 [研究ID_研究标题 (必选)] [文档类型 (必选)] Integrated analysis of safety 安全性综合分析 Iss Iss Analysis datasets 分析数据集 Analysis dataset adam 分析数据集 (ADaM) Analysis dataset legacy 分析数据集（遗留格式） Analysis program 分析程序 Analysis data definition 分析数据定义 Integrated analysis of efficacy 有效性综合分析 Ise Ise Analysis datasets 分析数据集 Analysis dataset adam 分析数据集 (ADaM) Analysis dataset legacy 分析数据集（遗留格式） Analysis program 分析程序 Analysis data definition 分析数据定义 Integrated analysis of clinical pharmacology 临床药理学综合分析 iscp iscp Analysis datasets 分析数据集 Analysis dataset adam 分析数据集 (ADaM) Analysis dataset legacy 分析数据集（遗留格式） Analysis program 分析程序 Analysis data definition 分析数据定义 Integrated analysis of immunogenicity 免疫原性综合分析 isi isi Analysis datasets 分析数据集 Analysis dataset adam 分析数据集 (ADaM) Analysis dataset legacy 分析数据集（遗留格式） Analysis program 分析程序 Analysis data definition 分析数据定义 5.3.5.4 Other Study reports and related information [study id_ study title (R)] [document type (R)] 5.3.5.4 其他研究报告及相关信息 [研究ID_研究标题 (必选)] [文档类型 (必选)] Antibacterial microbiology reports 抗菌微生物学报告 Antibacterial 抗菌 Special pathogens (e.g., fungi, parasites, mycobacteria) and immune modulator reports 特殊病原体（如真菌、寄生虫、分枝杆菌）和免疫调节剂报告 Special pathogen 特殊病原体 Antiviral reports 抗病毒报告 Antiviral 抗病毒 BIMO BIMO bimo bimo Human Factor 人为因素 HF validation protocol HF验证方案 HF validation report HF验证报告 HF validation other HF验证其他 5.3.6 Reports of postmarketing experience 5.3.6 上市后经验报告 Postmarketing periodic adverse event drug experience report description 上市后定期不良事件药物经验报告描述 5.4 Literature references 5.4 参考文献