WHITE PAPER: The route less traveled – Utilizing pre-clinical models to address challenges with novel drug delivery systems

Abstract

Novel drug delivery systems offer impactful solutions to improve upon existing pharmaceutical products. These delivery systems often lead to enhanced bioavailability as well as improved systemic and local safety profiles. In addition, assessing alternative delivery methods for existing drugs or biosimilars can benefit from efficient regulatory approval.

Here we discuss the importance of preclinical models in the evaluation of novel drug delivery systems, including toxicology, pharmacokinetics and dynamics, and patient considerations. The correct pharmaceutical assays must be carefully considered in order to help inform decision making in drug development from candidate selection to preparation for a clinical trial. We highlight the need to match preclinical development strategy with the right model systems, from in vitro cell monolayers to in vivo animal models of specific disease states. Novel ocular delivery systems are discussed in this context.