Chapter 14 - Opportunities for Implementing the 3 Rs in Drug Development and Safety Assessment Studies Using Nonhuman Primates

Abstract

There are many opportunities to benefit science and business through application of the “3 Rs” (replacement, reduction, and refinement) to nonhuman primate use in drug development and safety assessment studies. Scientifically driven approaches that consider individual studies on a case-by-case basis and how these studies fit into the drug development program as a whole can reduce the number of animals used without affecting the development outcome. Some examples include minimizing the number of dose groups, the number of animals per group, and the inclusion of recovery animals. In addition, studies that involve nonhuman primates can be refined through spacious and well-designed accommodation, effective environmental enrichment, housing in stable social groups, well-trained staff, use of the best humane technical practices, and positive reinforcement training of the animals to cooperate with procedures. All the elements within this chapter are interlinked and support improved animal welfare to generate more robust and reliable data to predict human safety.