Chapter 31 - Non-Clinical Drug Development

Abstract

From the first time a promising molecule is identified in a drug discovery and screening program to the time it enters a first-in-human (FIH) clinical trial, an enormous amount of scientific work and evaluation must be performed. Non-clinical development, as defined in this chapter, encompasses all of the activities that must take place before a new chemical entity can be administered to humans, as well as the extensive toxicology testing that continues after clinical trial initiation. As such, it not only spans the gap between drug discovery and clinical testing, but also provides all the key non-human pharmacological and safety information that must be generated under tightly controlled experimental conditions in order to satisfy regulatory review requirements. This chapter describes the general processes involved in the non-clinical development of a pharmaceutical agent, with specific examples taken from the field of oncology.