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

 
9780367400378: Vaccines: From Concept to Clinic: A Guide to the Development and Clinical Testing of Vaccines for Human Use

Inhaltsangabe

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?
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    Über die Autorin bzw. den Autor

    Lawrence C. Paoletti, Pamela M. McInnes

    Von der hinteren Coverseite

    This popular book delineates 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. Based on the results of the editors' own efforts to glean practical information on the steps necessary to manufacture, bottle, and test their vaccines for clinical trials, the book provides answers to numerous questions posed by researchers. The chapters outline basic approaches to vaccine development in its earliest stages, explain how to set up quantitative assessments of antibody responses to vaccines, and give helpful hints on making vaccines in the laboratory.

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