State-of-the-Art Pharmacy Services

Abstract

Phase I clinical studies form an important foundation for drug development and the eventual approval of life-saving therapies. The authors review an ideal suite of state-of-the-art pharmacy services in a Phase I clinical research unit that is tailored to the operations of early clinical research. These services span a continuum of practice, from compounding and drug preparation to the novel roles of protocol review, subject training for self-dosing, and drug administration. Also discussed are the topics of pharmacy involvement in drug accountability, manufacturing, and compounding, as well as drug blinding, dispensing, and dosing procedures. Finally, the authors outline the elements of an ideal pharmacy facility.