Science and Judgment in Establishing a Safe Starting Dose for First-in-Human Trials of Biopharmaceuticals

A number of regulatory guidance documents discuss various aspects of the transition from preclinical to clinical study of a novel biopharmaceutical. This article reviews the decision processes surrounding the determination of the initial dose of a novel biopharmaceutical agent to be administered to subjects in clinical trials. Keywords: biopharmaceutical agent; dosing; regulatory framework; preclinical safety evaluation