Non-Clinical Studies: The Foundations Of Successful Drug Development

Non-clinical studies are an early but essential component of drug development. As pressure builds to optimize efficiency, productivity and cost-management on the journey from bench to bedside, failing fast and sifting out truly viable from questionable drug candidates is more of a priority than ever before. This is especially critical when safety, the wellbeing of patients, and the reputation as well as commercial viability of pharmaceutical companies are at stake.

The US Food and Drug Administration (FDA) defines non-clinical laboratory studies as “in vivo or in vitro experiments in which test articles are studied prospectively in test systems under laboratory conditions to determine their safety”. This encompasses a wide range of animal and cell studies, addressing issues such as toxicity, genotoxicity, safety and efficacy pharmacology, pathological examinations and biological assays.