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Vaccines: From Concept to Clinic: A Guide to the Development and Clinical Testing of Vaccines for Human Use - Hardcover

 
9780849311680: Vaccines: From Concept to Clinic: A Guide to the Development and Clinical Testing of Vaccines for Human Use
Hardcover
ISBN 10: 0849311683 ISBN 13: 9780849311680
Publisher: CRC Press, 1998

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?

    • "synopsis" may belong to another edition of this title.

    About the Author

    Lawrence C. Paoletti, Pamela M. McInnes

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

    Publisher
    CRC Press
    Publication date
    1998
    Language
    English
    ISBN 10 
    0849311683
    ISBN 13 
    9780849311680
    Binding
    Hardcover
    Edition number
    1
    Number of pages
    224
    Editor
    Paoletti Lawrence C., McInnes Pamela