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Immunization of Adult Zebrafish for the Preclinical Screening of DNA-based Vaccines
Published on: October 30, 2018
Assuring the quality, safety, and efficacy of DNA vaccines
1National Institute for Biological Standards and Control, Hertfordshire, UK.
Abstract:
Scientists in academia whose research is aimed at the development of a novel vaccine or approach to vaccination may not always be fully aware of the regulatory process by which a candidate vaccine becomes a licensed product. This chapter will provide an overview of the regulatory process and will discuss in more detail the quality and pre-clinical safety issues of plasmid DNA vaccines intended for human use. It is useful for research scientists to be aware of these processes as the development of a novel vaccine could be problematic due to the starting material often being developed in a research laboratory under ill-defined conditions.
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