Nonclinical Research

Abstract

This chapter provides an overview of studies typically conducted in nonclinical drug development programs. Many of these studies are conducted under regulatory governance, and reports of them are included in regulatory submissions requesting marketing approval. Three areas of investigation are considered here: pharmacokinetics, pharmacology, and toxicology. The scientific rationale of the studies is addressed, along with a summary of appropriate regulatory guidance.

While nonhuman pharmacokinetic parameters are not perfect predictors of human pharmacokinetics, they constitute meaningful quantitative data that improve the chances of selecting the correct range of safe doses to test in humans. This dose selection is critically important to the success of clinical trials.