Bioanalytical Assays: Toxicokinetic

Non-clinical studies are conducted in drug development to demonstrate safety and efficacy for drug candidates prior to their use in clinical studies and throughout drug development. Toxicokinetic studies are conducted in the non-clinical phase to determine systemic exposure to a drug as a function of its dose. The data are also used to support the design of subsequent studies in different species, routes of administration, formulations, and dose levels, and to relate any toxicological findings to potential clinical safety and efficacy in humans. For regulated toxicokinetic studies, the study samples are analyzed by validated bioanalytical methods that should provide reliable and robust quantitative results. In this chapter we discuss how to determine toxicokinetic parameters in non-clinical studies and how to validate the bioanalytical methods that are used to analyze non-clinical samples, and we briefly discuss immunogenicity and the impact it can have on the toxicokinetic profile.