The Use Of Imaging, Biomonitoring And Microdosing In Human Volunteers To Improve Safety Assessments And Clinical Development

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 (< 100 mg/each administration) of drug candidates (phase 0 trials), coupled with ultra-sensitive analytical detection methods, are considered, with the use of examples. It is concluded that: (a) the above-mentioned techniques offer substantial scientific, financial and logistical benefits, while remaining largely non-invasive to volunteers; (b) recently developed procedures for real-time imaging, at the single cell level in humans require simplification; and (c) these advantages need to be more-widely publicised to increase the adoption of the methods into practice.