An Overview of Subchronic and Chronic Toxicology

This chapter will explore the regulatory requirement for subchronic and chronic toxicology studies, their design and purpose. The various routes of administration and volumes as well as dose level selection will be touched upon. The importance of species and strain selection will also be discussed with a particular focus on small molecule programs that will require a carcinogenicity study as part of the package. The requirement for subchronic and chronic juvenile studies and endpoints for some programs will also be highlighted.