Vaccinology: An Essential Guide outlines in a clear, practical format the entire vaccine development process, from conceptualization and basic immunological principles through to clinical testing and licensing of vaccines. With an outstanding introduction to the history and practice of vaccinology, it also guides the reader through the basic science relating to host immune responses to pathogens. Covering the safety, regulatory, ethical, and economic and geographical issues that drive vaccine development and trials, it also presents vaccine delivery strategies, novel vaccine platforms (including experimental vaccines and pathogens), antigen development and selection, vaccine modelling, and the development of vaccines against emerging pathogens and agents of bioterror. There are also sections devoted to veterinary vaccines and associated regulatory processes. Vaccinology: An Essential Guide is a perfect tool for designed for undergraduate and graduate microbiologists and immunologists, as well as residents, fellows and trainees of infectious disease and vaccinology. It is also suitable for all those involved in designing and conducting clinical vaccine trials, and is the ideal companion to the larger reference book Vaccinology: Principles and Practice.An Essential Guide Gregg N. Milligan, Alan D. T. Barrett. in animal models. Before the vaccine can be administered to humans, the US FDA requires GLP- regulated safety testing of the product in an animal model. ... the US FDA review board and expert committee, the sponsor will be advised of the decision to grant or deny licensure of the vaccine and conditions for use of the vaccine. ... to the NDA form.
|Author||:||Gregg N. Milligan, Alan D. T. Barrett|
|Publisher||:||John Wiley & Sons - 2015-02-16|