Discovery Studies: An Agile Approach To Early Data For Quicker Decisions

In the early stages of drug development, using non-GLP studies to quickly identify potential toxicity and explore the characteristics of drug candidates in live animals is crucial. This approach allows researchers to make faster and better-informed decisions about which drug candidates to pursue. The data from these animal models, particularly nonhuman primates (NHPs) due to their genetic and physiological similarities to humans, is essential for shaping the development strategy. By accessing this early discovery data, scientists can more rapidly refine drug candidates and identify promising therapeutic targets, novel delivery methods, and markers that show how a drug affects the body.

This issue explores the benefits and features of non-GLP discovery studies and highlights new trends in this critical early phase of drug development. We also feature two case studies from our Sacramento site, showcasing discovery studies that evaluated how a test article was distributed in the body under specific experimental conditions.