Microdosing Studies in Humans
Drugs in R&D January 1, 2008 Martin Bauer, Cláudia Wagner, Oliver Langer 52 citations
Positron emission tomography (PET)-microdosing involves giving human subjects a carbon-11- or fluorine-18-labeled drug candidate in microgram amounts to track the drug's concentration over time in targeted body tissues. Because only tiny amounts of unlabeled drug are used, toxicological risk is very low, and regulatory authorities require less preclinical safety testing than for conventional phase 1 studies. Microdose studies are becoming more important in clinical drug research because they can shorten development timelines and reduce costs. The review covers current PET applications in anticancer, anti-infective, and central nervous system drug research.