Vaccines: From Concept to Clinic
Lawrence C. Paoletti, Pamela McInnes, "Vaccines: From Concept to Clinic: A Guide to the Development and Clinical Testing of Vaccines for Human Use"
Publisher: Informa HealthCare; 1 edition | 1998-07-29 | 210 Pages | ISBN: 0849311683 | PDF | 1.3 MB
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:oHow do I identify antigens that would produce effective vaccines?oCan I produce a clinical lot of vaccine in my laboratory?oHow should a vaccine be bottled?oWhich FDA expectations must I meet?oWhat is an IND application and how do I file it?oWhich CFRs apply to production of a vaccine?
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