By Sherilyn Adcock, Ph.D., George Atiee, M.D., John Sramek, Pharm.D.
Phase I clinical studies form an important foundation for drug development and eventual approval of life-saving therapies. Potential drug candidates are screened for entry into Phase I trials by extensive in-vitro testing and tolerance in several animal species. Early in-vitro testing establishes potential mechanisms of action, such as binding to a receptor or enzyme. Animal toxicology at large doses is used to determine a small, safe starting dose for first-in- human trials. This article reviews the role of the pharmacy in a modern Phase I clinical research unit (CRU). In light of limited published literature about pharmacy services in a Phase I setting, this article explores the inner workings of a highly active pharmacy unit.