Abstract

Nuclear imaging can play an important role in the development of new medicines. By labelling a drug with a radionuclide, its biodistribution throughout the body can be visualised. This provides visual and quantitative data on uptake within and outside the targeted disease area. The low radioactivity required for this makes it suitable for clinical trials with a low, subtherapeutic dose. Such trials, commonly referred to as Phase 0 or early Phase 1, adhere to a special regulatory framework: exploratory trials. This framework was introduced by the FDA and EMA about twenty years ago to improve and accelerate drug development by bridging the gap between preclinical and clinical research. The use of nuclear imaging allows harnessing the full potential of this first-in-human study.