Investigator’s Brochure (IB)

Purpose

• The IB is a comprehensive document that provides investigators and study staff with the information necessary to conduct a clinical trial safely and effectively.

Content

1. Title Page and Confidentiality Statement

2. Table of Contents

3. Summary

   • Overview of key information.

4. Introduction

   • Chemical Name and Structure: Description of the drug.

   • Mechanism of Action: Pharmacological properties.

5. Physical, Chemical, and Pharmaceutical Properties

   • Formulation Details: Stability, storage, handling.

6. Non-Clinical Studies

   • Pharmacology: Efficacy data.

   • Pharmacokinetics and Metabolism: ADME profiles.

   • Toxicology: Safety data.

7. Effects in Humans

   • Clinical Experience: Previous studies, if any.

   • Safety and Efficacy Data: Adverse events, therapeutic outcomes.

8. Summary of Data and Guidance for the Investigator

   • Risk-Benefit Assessment

   • Dosage Guidelines

   • Monitoring Procedures

Updates of Investigator’s Brochure

• Annual Revisions: Reflect new data.

• Amendments: As significant new information becomes available.