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Vaccines Lawrence C. Paoletti

Vaccines By Lawrence C. Paoletti

Vaccines by Lawrence C. Paoletti


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Vaccines Summary

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

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 Lawrence C. Paoletti

    Lawrence C. Paoletti, Pamela M. McInnes

    Table of Contents

    Identification of Vaccine Targets. Use of Animals for Vaccine Development. Validation and Standardization of Serologic Methods for Evaluation of Clinical Immune Response to Vaccines. Considerations in the Production of Vaccines for Use in Phase 1 Clinical Trials and Preparation of the Manufacturer's Protocol. Helpful Hints for Preparing an IND Application. IND Application Submissions for Vaccines: Perspectives of IND Reviewers.
    Technology Transfer: What You Always Wanted to Know But Were Afraid to Ask. Development of a Transmission-Blocking Vaccine: Malaria, Mosquitoes, and Medicine. The Victories and Vexations of Vaccine Production -The Varicella Vaccine.

    Additional information

    NLS9780367400378
    9780367400378
    0367400375
    Vaccines: From Concept to Clinic: A Guide to the Development and Clinical Testing of Vaccines for Human Use by Lawrence C. Paoletti
    New
    Paperback
    Taylor & Francis Ltd
    2019-09-11
    224
    N/A
    Book picture is for illustrative purposes only, actual binding, cover or edition may vary.
    This is a new book - be the first to read this copy. With untouched pages and a perfect binding, your brand new copy is ready to be opened for the first time

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