Vaccine Pre-clinical Toxicology Testing
Vaccine Designs/Concepts
Correlates of Immunity
Assay Development
Animal Models
Immunologic Adjuvants
Variation
International Studies
Behavior
Ethics
Vaccine Design and Methodologic
Issues
Assay Validation
|
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
1 SRI International,
Menlo Park, CA
2 U.S. Public Health Service,
NIH/NIAID, Bethesda, MD
3 NIH/NIAID/Div. of AIDS,
Bethesda, MD
4 FDA/CBER/Office of Vaccines
Research & Review/Div. of Vaccines & Related Products Applications,
Rockville, MD
|