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

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

Editat de Lawrence C. Paoletti, Pamela McInnes
en Limba Engleză Paperback – 11 sep 2019
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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    Specificații

    ISBN-13: 9780367400378
    ISBN-10: 0367400375
    Pagini: 224
    Dimensiuni: 178 x 254 x 13 mm
    Greutate: 0.41 kg
    Ediția:1
    Editura: CRC Press
    Colecția CRC Press

    Public țintă

    Academic and Professional Practice & Development

    Cuprins

    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.

    Descriere

    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.