Title: Vaccines: From Concept to Clinic: A Guide to the Development and Clinical Testing of Vaccines for Human Use
Publisher: CRC Press
Publication Date: 2019
Language: English
ISBN 10: 0367400375
ISBN 13: 9780367400378
Binding: Soft cover
Condition: New

About this title

Synopsis

Designed with academic vaccine researchers in mind, this book presents a road map of how a vaccine develops from an idea in a researcher's imagination, to the lab bench, through preclinical evaluation, and into the clinic for safety and immunogenicity. The result of the editors' own efforts to glean practical information on the steps necessary to manufacture, bottle, and test their vaccines for clinical trials, this book provides answers to researcher questions such as:

How do I identify antigens that would produce effective vaccines?

Can I produce a clinical lot of vaccine in my laboratory?

How should a vaccine be bottled?

Which FDA expectations must I meet?

What is an IND application and how do I file it?

Which CFRs apply to production of a vaccine?

About the Author

Lawrence C. Paoletti, Pamela M. McInnes

"About this title" may belong to another edition of this title.

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