Chapter 19 - Safety and Efficacy Evaluation Using Nonhuman Primates

Abstract

Nonhuman primates play a critical role in modern drug development, an area of research which accounts for a significant number of the primates used in current scientific investigation. Due to dramatic similarities to humans in drug metabolism, cardiovascular response, neurological function, fetal development and reproduction, and immune response to molecules, the primate is often the preferred or only animal model that can produce data relevant to humans. The regulatory and scientific drivers for primate use in drug development and safety assessment are reviewed, as well as some of the more prominent investigative areas.