Table of Content of ICH CTD
Module 1: Administrative Information and Prescribing Information
1.1 Table of Contents of the Submission Including Module 1
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)
INTRODUCTION
2.3.S DRUG SUBSTANCE (NAME, MANUFACTURER)
2.3.S.1 General Information (name, manufacturer)
2.3.S.2 Manufacture (name, manufacturer)
2.3.S.3 Characterisation (name, manufacturer)
2.3.S.4 Control of Drug Substance (name, manufacturer)
2.3.S.5 Reference Standards or Materials (name, manufacturer)
2.3.S.6 Container Closure System (name, manufacturer)
2.3.S.7 Stability (name, manufacturer).
2.3.P DRUG PRODUCT (NAME, DOSAGE FORM)
2.3.P.1 Description and Composition of the Drug Product (name, dosage form)
2.3.P.2 Pharmaceutical Development (name, dosage form)
2.3.P.3 Manufacture (name, dosage form)
2.3.P.4 Control of Excipients (name, dosage form)我一定会成功
2.3.P.5 Control of Drug Product (name, dosage form)
2.3.P.6 Reference Standards or Materials (name, dosage form)
2.3.P.7 Container Closure System (name, dosage form)
2.3.P.8 Stability (name, dosage form)
2.3.A APPENDICES
2.3.A.1 Facilities and Equipment (name, manufacturer)
2.3.A.2 Adventitious Agents Safety Evaluation (name, dosage form, manufacturer)
2.3.A.3 Excipients
2.3.R 手机没有网络REGIONAL INFORMATION
2.4 Nonclinical Overview
2.4.1 Overview of the nonclinical testing strategy
2.4.2 Pharmacology
2.4.3 Pharmacokinetics
面痣图解男2.4.4 Toxicology
2.4.5 Integrated overview and conclusions
2.4.6 List of literature references
2.5 Clinical Overview
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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
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
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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
世纪金榜教学资源网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
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