Ocular Pharmacokinetic and Safety Studies

Ocular pharmacokinetic (PK) and safety studies in animals are essential components in the drug development pipeline. Ocular PK studies are designed to assess absorption, distribution, metabolism, and elimination of test articles by quantifying tissue levels in the whole eye or in ocular sub-tissues. In contrast, safety studies evaluate tolerability and the toxicological profile of test articles. This chapter will provide insight into the types of ocular sub-tissues that can be collected from the different preclinical laboratory species in the context of species differences in ocular anatomy and discuss clinically relevant routes of ocular test article delivery. Subsequently, clinical, structural, and electrodiagnostic approaches to assess the safety profile of test articles are being discussed.