Chapter 12 - Toxicologic Pathology and Background Lesions of Nonhuman Primates

Abstract

Toxicologic pathology plays a critical role in the safety assessment of nonhuman primates used in drug development through the identification and interpretation of microscopic tissue changes. The discrimination between background changes, or those changes that are incidental/spontaneous, and true test article-related findings is of paramount importance and can be challenging. The practice of toxicologic pathology is both an art and a science, and the accurate identification and interpretation of histopathologic changes relies on the experience of the pathologist as well as utilization of as much applicable information as possible. This includes study design, organ weights, treatment, and historical control data as well as the use of proper terminology, thresholds, and quality control. Also intrinsic to this process is having a solid understanding of the common background microscopic changes in nonhuman primates that are commonly used in nonclinical research.