Accelerator Mass Spectrometry and Positron Emission Tomography in Human Microdosing

Abstract

Human microdosing study is one type of exploratory phase I investigation supported by both U.S. and European regulatory agencies. Very small subpharmacologic doses of a drug are used in humans to obtain an early assessment of pharmacokinetic properties in humans. This has the potential of reducing the number of preclinical animal studies, essential for conducting early clinical human studies, differentiating between good and bad candidate drugs early, and speeding up the early phases of drug development. Human microdosing, as will be outlined in this chapter, is a newly established and still evolving concept, around which knowledge is beginning to accumulate.