7.5 APPENDIX 2

TABLE OF CONTENTS OF INVESTIGATOR’S BROCHURE (Example)

- Confidentiality Statement (optional)…………………………………………………………………

- Signature Page (optional)…………………………………………………………………………………

1 Table of Contents ……………………………………………………………………………………………

2 Summary ……………………………………………………………………………………………………….

3 Introduction ……………………………………………………………………………………………………

4 Physical, Chemical, and Pharmaceutical Properties and Formulation ………………..

5 Nonclinical Studies …………………………………………………………………………………………

5.1 Nonclinical Pharmacology ……………………………………………………………………………….

5.2 Pharmacokinetics and Product Metabolism in Animals ……………………………………..

5.3 Toxicology ………………………………………………………………………………………………………

6 Effects in Humans …………………………………………………………………………………………..

6.1 Pharmacokinetics and Product Metabolism in Humans ……………………………………..

6.2 Safety and Efficacy ………………………………………………………………………………………….

6.3 Marketing Experience ……………………………………………………………………………………..

7 Summary of Data and Guidance for the Investigator …………………………………………

NB: References on 1. Publications

2. Reports

These references should be found at the end of each chapter

Appendices (if any)