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Vaccines: From Concept to Clinic: A Guide to the Development and Clinical Testing of Vaccines for Human Use by Lawrence C. Paoletti 9780367400378
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Vaccines: From Concept to Clinic: A Guide to the Development and Clinical Testing of Vaccines for Human Use by Lawrence C. Paoletti 9780367400378

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Description

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


    Book Information
    ISBN 9780367400378
    Author Lawrence C. Paoletti
    Format Paperback
    Page Count 224
    Imprint CRC Press
    Publisher Taylor & Francis Ltd
    Weight(grams) 408g

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