title: Microdosing studies in humans: the role of positron emission tomography.
abstract: Positron emission tomography (PET)-microdosing comprises the administration of a carbon-11- or fluorine-18-labelled drug candidate to human subjects in order to describe the drug's concentration-time profile in body tissues targeted for treatment. As PET microdosing involves the administration of only microgram amounts of unlabelled drug, the potential toxicological risk to human subjects is very limited. Consequently, regulatory authorities require reduced preclinical safety testing as compared with conventional phase 1 studies. Microdose studies are gaining increasing importance in clinical drug research as they have the potential to shorten time-lines and cut costs along the critical path of drug development. Current applications of PET in anticancer, anti-infective and CNS system drug research are reviewed.
authors.affiliation: Department of Clinical Pharmacology, Medical University Vienna, Vienna, Austria.
authors.forename: Martin
authors.initials: M
authors.lastname: Bauer
authors.forename: Claudia Christina
authors.initials: CC
authors.lastname: Wagner
authors.forename: Oliver
authors.initials: O
authors.lastname: Langer
mesh_terms: D002250:Carbon Radioisotopes; D002853:Chromatography, Liquid; D015195:Drug Design; D006801:Humans; D004364:Pharmaceutical Preparations / Q000008:administration & dosage*; D010599:Pharmacokinetics; D049268:Positron-Emission Tomography / Q000379:methods*; D053719:Tandem Mass Spectrometry
chemical_list: D002250:Carbon Radioisotopes; D004364:Pharmaceutical Preparations