Investigators Brochure - ICH

Question 1

Purpose

Answer 1

To produve the investigators and others involved in the trial witht the information to facilitate their understanding of the rational for, and their compliance with many key features

Question 2

Who is responsible for IB

Answer 2

Generally, sponsor is responsible for ensuring the IB is up to date
Investigators are responsible for providing up to date IB to the responsible IRBs/IECs

Question 3

Contents

Answer 3

1. Table of contents
2. Summary
3. Introduction
4. phsycial, chemical, and pharmaceutical properties and formulation
5. nonclinila studies
6. nonclinical pharmacology
7. pharmacokinetics and Product metbolism in animals
8. Toxicology
9. Effects in humans
10. Pharamokinetics in humans
11. Safety and Efficacy
12. Marketing experience
13. Summary of Data and Guidance for the investigator