The Use of Imaging, Biomonitoring and Microdosing in Human Volunteers to Improve Safety Assessments and Clinical Development

Abstract The scientific rationale for undertaking first-in-human volunteer studies at earlier than the usual stages of pharmaceutical development involving efficacy and safety assessment, within the stipulations of the Declaration of Helsinki, is discussed. The advantages and disadvantages of various clinical techniques, including diagnostic imaging, biomonitoring to estimate levels of endogenous exposure from levels of biomarkers in body fluids, and the administration of microdose levels (