Chapter 35 - Toxicology testing: in vivo mammalian models

Abstract

The scientifically justified primary reason for animal studies, supporting the requirement by worldwide regulatory agencies, is hazard identification to address human safety. Several key animal models, including mouse, rat, rabbit, dog, and nonhuman primate, are briefly described in the context of general and specialized toxicity testing. A few key clinical pathology endpoints are provided for reference. Importantly concordance of animal studies supporting human safety and characterizing the potential for adverse events has been shown to be of great societal value, particularly in drug development, but also key for industrial chemicals and food safety. The majority of this chapter will focus on species used to support United States Food and Drug Administration-regulated products, although most species used in toxicity testing are in common across regulatory agencies and industries.