Chapter 30 - Nonclinical drug development

Abstract

Prior to entering clinical testing, a new molecular entity must first undergo a series of rigorous scientific assessments. These include pharmacologic evaluations of safety and efficacy, toxicology testing under carefully controlled conditions, and the thorough characterization of manufacturing processes. Nonclinical development, which spans the gap between drug discovery and clinical testing, encompasses all of these activities. The data resulting from these evaluations are subject to rigorous regulatory review prior to the initiation of first-in-human (FIH) trials. This chapter describes the general process of nonclinical drug development, including the requirements for an FDA IND filing with specific examples taken from the field of oncology.