Malaria Control and Elimination by Frédéric Ariey & Frédérick Gay & Robert Ménard

Author:Frédéric Ariey & Frédérick Gay & Robert Ménard
Language: eng
Format: epub
ISBN: 9781493995509
Publisher: Springer New York

2 Preclinical Vaccine Development: From Proof-of-Concept to Regulatory Submission for Phase 1 Clinical Trial

Vaccines represent the most diverse class of product candidates in the pharmaceutical industry (e.g., live attenuated or inactivated pathogens, purified or recombinant proteins, polysaccharide and conjugated vaccines, DNA vaccines, therapeutic vaccines, adjuvants). Hence, the types of product characterization, quality assessment, and safety evaluation involved in the preclinical development of new vaccines are numerous and complex [1]. Preclinical testing is a prerequisite to move a candidate vaccine from the laboratory to the clinic and includes all aspects of testing, product characterization, proof-of-concept/immunogenicity studies, and safety testing in animals conducted prior to introducing the product into humans [2].

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