Module 1: Administrative Information and Prescribing Information
1.1 Table of Contents of the Submission Including Module
1.2 Documents Specific to Each Region (for example, application forms, prescribing information)
Module 2: Common Technical Document Summaries
2.1 Common Technical Document Table of Contents (Modules 2-5)
2.2 CTD Introduction
2.3 Quality Overall Summary(QOS) 质量综述
INTRODUCTION
2.3.S DRUG SUBSTANCE (NAME, MANUFACTURER) 原料药
2.3.S.1 General Information (name, manufacturer) 基本信息
2.3.S.2 Manufacture (name, manufacturer) 生产
2.3.S.3 Characterisation (name, manufacturer) 特性鉴定
2.3.S.4 Control of Drug Substance (name, manufacturer) 料药的质量控制
2.3.S.5 Reference Standards or Materials (name, manufacturer) 对照品
一个小锅炒豆豆2.3.S.6 Container Closure System (name, manufacturer) 包装系统
2.3.S.7 Stability (name, manufacturer).稳定性
2.3.P DRUG PRODUCT (NAME, DOSAGE FORM) 制剂
2.3.P.1 Description and Composition of the Drug Product (name, dosage form) 剂型及产品组成
2.3.P.2 Pharmaceutical Development (name, dosage form) 产品开发
2.3.P.3 Manufacture (name, dosage form) 生产
2.3.P.4 Control of Excipients (name, dosage form)辅料的控制
2.3.P.5 Control of Drug Product (name, dosage form) 制剂的质量控制
2.3.P.6 Reference Standards or Materials (name, dosage form)对照品
2.3.P.7 Container Closure System (name, dosage form) 包装系统
2.3.P.8 Stability (name, dosage form)稳定性
2.3.A APPENDICES 附录
2.3.A.1 Facilities and Equipment (name, manufacturer) 设施和设备
2.3.A.2 Adventitious Agents Safety Evaluation (name, dosage form, manufacturer) 外源因子的安全性评价
2.3.A.3 Excipients 辅料
2.3.R REGIONAL INFORMATION 区域性信息
2.4 Nonclinical Overview
2.4.1 Overview of the nonclinical testing strategy
2.4.2 Pharmacology
2.4.3 Pharmacokinetics
2.4.4 Toxicology
2.4.5 Integrated overview and conclusions
2.4.6 List of literature references
2.5 Clinical Overview三年级语文生字
2.5.1 Product Development Rationale
2.5.2 Overview of Biopharmaceutics
2.5.3 Overview of Clinical Pharmacology
2.5.4 Overview of Efficacy
2.5.5 Overview of Safety
2.5.6 Benefits and Risks Conclusions
2.5.7 Literature References
2.6 Nonclinical Written and Tabulated Summaries
Pharmacology
Pharmacokinetics
Toxicology
2.6.1 Introduction
2.6.2 Pharmacology Written Summary
2.6.2.1 Brief Summary
2.6.2.2 Primary Pharmacodynamics
2.6.2.3 Secondary Pharmacodynamics
中非共和国总统2.6.2.4 Safety Pharmacology
2.6.2.5 Pharmacodynamic Drug Interactions
2.6.2.6 Discussion and Conclusions
2.6.2.7 Tables and Figures
2.6.3 Pharmacology Tabulated Summary (e Appendix B)
2.6.
3.1 Pharmacology: Overview
2.6.
3.2 Primary Pharmacodynamics*
2.6.
3.3 Secondary Pharmacodynamics*
2.6.
3.4 Safety Pharmacology
2.6.
3.5 Pharmacodynamic Drug Interactions*
2.6.4 Pharmacokinetics Written Summary
2.6.4.1 Brief Summary
2.6.4.2 Methods of Analysis
2.6.4.3 Absorption
2.6.4.4 Distribution
2.6.4.5 Metabolism (interspecies comparison)
2.6.4.6 Excretion
2.6.4.7 Pharmacokinetic Drug Interactions
2.6.4.8 Other Pharmacokinetic Studies
2.6.4.9 Discussion and Conclusions
2.6.4.10 Tables and Figures
2.6.5 Pharmacokinetics Tabulated Summary (e Appendix B)
2.6.5.1 Pharmacokinetics: Overview
2.6.5.2 Analytical Methods and Validation Reports*
2.6.5.3 Pharmacokinetics: Absorption after a Single Do
2.6.5.4 Pharmacokinetics: Absorption after Repeated Dos
2.6.5.5 Pharmacokinetics: Organ Distribution
2.6.5.6 Pharmacokinetics: Plasma Protein Binding
2.6.5.7 Pharmacokinetics: Study in Pregnant or Nursing Animals
2.6.5.8 Pharmacokinetics: Other Distribution Study
2.6.5.9 Pharmacokinetics: Metabolism In Vivo
2.6.5.10 Pharmacokinetics: Metabolism In Vitro
2.6.5.11 Pharmacokinetics: Possible Metabolic Pathways
2.6.5.12 Pharmacokinetics: Induction/Inhibition of Drug-Metabolizing Enzymes 2.6.5.13 Pharmacokinetics: Excretion
2.6.5.14 Pharmacokinetics: Excretion into Bile
2.6.5.15 Pharmacokinetics: Drug-Drug Interactions
2.6.5.16 Pharmacokinetics: Other
2.6.6 Toxicology Written Summary
2.6.6.1 Brief Summary
2.6.6.2 Single-Do Toxicity
2.6.6.3 Repeat-Do Toxicity (including supportive toxicokinetics evaluation)
2.6.6.4 Genotoxicity
2.6.6.5 Carcinogenicity (including supportive toxicokinetics evaluations)
2.6.6.6 Reproductive and Developmental Toxicity (including range-finding studies and supportive toxicokinetics evaluations)
2.6.6.7 Local Tolerance
2.6.6.8 Other Toxicity Studies (if available)
2.6.6.9 Discussion and Conclusions
2.6.6.10 Tables and Figures
2.6.7 Toxicology Tabulated Summary (e Appendix B)
2.6.7.1 Toxicology: Overview
2.6.7.2 Toxicokinetics: Overview of Toxicokinetics Studies
2.6.7.3 Toxicokinetics: Overview of Toxicokinetics Data
2.6.7.4 Toxicology: Drug Substance
2.6.7.5 Single-Do Toxicity
2.6.7.6 Repeat-Do Toxicity: Non-Pivotal Studies
2.6.7.7 Repeat-Do Toxicity: Pivotal Studies
2.6.7.8 Genotoxicity: In Vitro
2.6.7.9 Genotoxicity: In Vivo
2.6.7.10 Carcinogenicity
2.6.7.11 Reproductive and Developmental Toxicity: Non-Pivotal Studies
2.6.7.12 Reproductive and Developmental Toxicity – Fertility and Early Embryonic Development to Implantation (Pivotal)
2.6.7.13 Reproductive and Developmental Toxicity –Effects on Embryo-Fetal Development (Pivotal)
2.6.7.14 Reproductive and Developmental Toxicity –Effects on Pre- and Postnatal Development, Including Maternal Function (Pivotal)
2.6.7.15 Studies in Juvenile Animalsa
2.6.7.16 Local Tolerance
2.6.7.17 Other Toxicity Studies
2.7 Clinical Summary
2.7.1 Summary of Biopharmaceutic Studies and Associated Analytical Methods 2.7.1.1 Background and Overview
2.7.1.2 Summary of Results of Individual Studies
2.7.1.3 Comparison and Analys of Results Across Studies
2.7.1.4 Appendix
2.7.2 Summary of Clinical Pharmacology Studies
2.7.2.1 Background and Overview
2.7.2.2 Summary of Results of Individual Studies
2.7.2.3 Comparison and Analys of Results Across Studies
2.7.2.4 Special Studies玉米面条怎么煮
2.7.2.5 Appendix海带红烧肉
2.7.3 Summary of Clinical Efficacy
2.7.
3.1 Background and Overview of Clinical Efficacy
2.7.
3.2 Summary of Results of Individual Studies
2.7.
3.3 Comparison and Analys of Results Across Studies
2.7.
3.3.1 Study Populations
2.7.儿童晕车最有效的方法
3.3.2 Comparison of Efficacy Results of all Studies
2.7.
3.3.3 Comparison of Results in Sub-populations
2.7.
3.4 Analysis of Clinical Information Relevant to Dosing Recommendations
2.7.
3.5 Persistence of Efficacy and/or Tolerance Effects
2.7.
3.6 Appendix
2.7.4 Summary of Clinical Safety
2.7.4.1 Exposure to the Drug
2.7.4.1.1 Overall Safety Evaluation Plan and Narratives of Safety Studies
2.7.4.1.2 Overall Extent of Exposure
2.7.4.1.3 Demographic and Other Characteristics of Study Population
2.7.4.2 Adver Events
2.7.4.2.1 Analysis of Adver Events
2.7.4.2.2 Narratives
2.7.4.3 Clinical Laboratory Evaluations
2.7.4.4 Vital Signs, Physical Findings, and Other Obrvations Related to Safety
2.7.4.5 Safety in Special Groups and Situations
2.7.4.5.1 Intrinsic Factors
2.7.4.5.2 Extrinsic Factors
2.7.4.5.3 Drug Interactions
2.7.4.5.4 U in Pregnancy and Lactation
2.7.4.5.5 Overdo
护士P
2.7.4.5.6 Drug Abu
2.7.4.5.7 Withdrawal and Rebound
2.7.4.5.8 Effects on Ability to Drive or Operate Machinery or Impairment of Mental Ability
2.7.4.6 Post-marketing Data
2.7.4.7 Appendix
2.7.5 Literature References
鹬蚌相争的意思
2.7.6 Synops of Individual Studies
Module 3: Quality
3.1 Table of Contents of Module 3
3.2 Body of Data(数据汇总)
3.2.S DRUG SUBSTANCE (NAME, MANUFACTURER) 原料药
3.2.S.1 General Information (name, manufacturer) 基本信息
3.2.S.1.1 Nomenclature (name, manufacturer) 药品名称
3.2.S.1.2 Structure (name, manufacturer) 结构
3.2.S.1.3 General Properties (name, manufacturer) 基本性质
3.2.S.2 Manufacture (name, manufacturer) 生产
3.2.S.2.1 Manufacturer(s) (name, manufacturer) 生产商
3.2.S.2.2 Description of Manufacturing Process and Process Controls (name, manufacturer) 生产工艺和工艺控制
3.2.S.2.3 Control of Materials (name, manufacturer) 物料控制
3.2.S.2.4 Controls of Critical Steps and Intermediates (name, manufacturer) 关键步骤和中间体的控制
3.2.S.2.5 Process Validation and/or Evaluation (name, manufacturer) 工艺验证和/或评价
3.2.S.2.6 Manufacturing Process Development (name, manufacturer) 生产工艺的开发
3.2.S.3 Characterisation (name, manufacturer) 特性鉴定
3.2.S.3.1 Elucidation of Structure and other Characteristics (name, manufacturer) 结构和理化性质
3.2.S.3.2 Impurities (name, manufacturer) 杂质
3.2.S.4 Control of Drug Substance (name, manufacturer) 原料药的质量控制
3.2.S.
4.1 Specification (name, manufacturer) 质量标准
3.2.S.
4.2 Analytical Procedures (name, manufacturer) 分析方法
3.2.S.
4.3 Validation of Analytical Procedures (name, manufacturer) 分析方法的验证3.2.S.4.4 Batch Analys (name, manufacturer) 批分析
3.2.S.
4.5 Justification of Specification (name, manufacturer) 质量标准制定依据
3.2.S.5 Reference Standards or Materials (name, manufacturer)对照品/标准品3.2.S.6 Container Closure System (name, manufacturer) 包装系统
3.2.S.7 Stability (name, manufacturer) 稳定性
3.2.S.7.1 Stability Summary and Conclusions (name, manufacturer) 稳定性总结和结论
3.2.S.7.2 Post-approval Stability Protocol and Stability Commitment (name, manufacturer) 批准后稳定性研究方案和承诺
3.2.S.7.3 Stability Data (name, manufacturer)稳定性数据
3.2.P DRUG PRODUCT (NAME, DOSAGE FORM) 制剂
3.2.P.1 Description and Composition of the Drug Product (name, dosage form)剂型及产品组成
3.2.P.2 Pharmaceutical Development (name, dosage form) 产品开发
3.2.P.2.1 Components of the Drug Product (name, dosage form) 处方组成
3.2.P.2.1.1 Drug Substance (name, dosage form) 原料药
3.2.P.2.1.2 Excipients (name, dosage form)辅料
3.2.P.2.2 Drug Product (name, dosage form)制剂
3.2.P.2.2.1 Formulation Development (name, dosage form)处方开发过程
3.2.P.2.2.2 Overages (name, dosage form)过量投料
3.2.P.2.2.3 Physicochemical and Biological Properties (name, dosage form)制剂相关特性
3.2.P.2.3 Manufacturing Process Development (name, dosage form)生产工艺的开发3.2.P.2.4 Container Closure System (name, dosage form)包装系统
3.2.P.2.5 Microbiological Attributes (name, dosage form)微生物属性
3.2.P.2.6 Compatibility (name, dosage form)相容性
3.2.P.3 Manufacture (name, dosage form)生产
3.2.P.3.1 Manufacturer(s) (name, dosage form)生产商
3.2.P.3.2 Batch Formula (name, dosage form)批处方
3.2.P.3.3 Description of Manufacturing Process and Process Controls (name, dosage form)生产工艺和工艺控制
3.2.P.3.4 Controls of Critical Steps and Intermediates (name, dosage form)关键步骤和中间体的控制
3.2.P.3.5 Process Validation and/or Evaluation (name, dosage form)工艺验证和/或评价
