The Use of Microdosing in the Development of Small Organic and Protein Therapeutics
Journal of Nuclear Medicine May 25, 2017 Mats Bergström 31 citations
Microdosing as a regulatory concept was introduced to facilitate exploratory studies in humans. The concept involves the use of very low doses of a radionuclide-labeled compound for imaging studies or for assessing plasma pharmacokinetics using equipment that has a highly sensitive readout. The supporting principle is that use of these low doses for a limited time in well-controlled, small...