title: Nonclinical Safety Testing of RNA Vaccines.
abstract: In this chapter, we first consider the overall goal of nonclinical safety testing during drug development and have a brief overview of its regulatory background. We then discuss some basic requirements of safety/toxicity testing before concentrating on the safety testing of RNA vaccines and developing a sample RNA vaccine safety testing program.
authors.affiliation: Aurigon GmbH, Machtlfinger Str. 13, 81379, Munich, Germany. gundel.hager@aurigon.de.
authors.forename: Gundel
authors.initials: G
authors.lastname: Hager
mesh_terms: D000818:Animals; D004353:Drug Evaluation, Preclinical / Q000379:methods; D006801:Humans; D012313:RNA / Q000009:adverse effects* / Q000276:immunology*; D012449:Safety; D018675:Toxicity Tests / Q000379:methods; D014612:Vaccines / Q000009:adverse effects* / Q000276:immunology*
chemical_list: D014612:Vaccines; D012313:RNA
keywords: ERA; GLP; Guidelines; Immunogenicity; NOAEL; Safety and toxicity testing; Safety pharmacology; Study protocol; Study report