Vaccine Pre-clinical Toxicology Testing

by P.Y. Chang, Ph.D.¹, CDR Rebecca Sheets, Ph.D.²,
Stuart Shapiro, M.D., Ph.D.³, Sally Hargus, Ph.D.,⁴
and Marion Gruber, Ph.D.⁴

Scope of this document

Introduction

Flowchart 1: Product Development of a Vaccine Candidate

Brief Overview of Vaccine Manufacture

Flowchart 2: Vaccine Manufacture

Pre-clinical Safety Testing of Candidate Vaccines

Flowchart 3: Pre-clinical Safety Testing

Pre-IND and IND Submissions

Flowchart 4: Preparing an Investigational New Drug Application

Summary

Glossary

Acknowledgements

About the authors

Additional flowchart detail