Resources for Researchers
Preclinical Development (Diagnostics, Therapeutics, and Vaccines)
Develop targets
Conduct in vitro testing
Conduct in vivo testing
Develop/refine animal models
Utilize preclinical planning and evaluation services
Identify, optimize, synthesize, characterize, formulate lead candidate, and/or chemistry and manufacturing
Develop/evaluate assay or device
Compare and/or evaluate candidate device against predicate device
Assess immunogenicity
Conduct toxicology and/or genotoxicity studies
Evaluate pharmacokinetics, safety pharmacology
Formulate and produce pilot lots
Obtain regulatory support for compiling documentation necessary for submission of an Investigational New Drug (IND) application and/or Master Files to the Food and Drug Administration (FDA)
