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OverviewDesigned 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? Full Product DetailsAuthor: Lawrence C. Paoletti , Pamela McInnesPublisher: Taylor & Francis Ltd Imprint: CRC Press Weight: 0.408kg ISBN: 9780367400378ISBN 10: 0367400375 Pages: 224 Publication Date: 11 September 2019 Audience: Professional and scholarly , Professional & Vocational Format: Paperback Publisher's Status: Active Availability: In Print  This item will be ordered in for you from one of our suppliers. Upon receipt, we will promptly dispatch it out to you. For in store availability, please contact us. Table of ContentsIdentification 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.ReviewsAuthor InformationLawrence C. Paoletti, Pamela M. McInnes Tab Content 6Author Website:Countries AvailableAll regions |
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