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01.03.2008 | Review Article

Microdosing Studies in Humans

The Role of Positron Emission Tomography

verfasst von: Martin Bauer, Claudia Christina Wagner, Dr Oliver Langer

Erschienen in: Drugs in R&D | Ausgabe 2/2008

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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.

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Titel: Microdosing Studies in Humans
The Role of Positron Emission Tomography
verfasst von: Martin Bauer
Claudia Christina Wagner
Dr Oliver Langer
Publikationsdatum: 01.03.2008
Verlag: Springer International Publishing
Erschienen in: Drugs in R&D / Ausgabe 2/2008
Print ISSN: 1174-5886
Elektronische ISSN: 1179-6901
DOI: https://doi.org/10.2165/00126839-200809020-00002

Live-Webinar "Urologie und Sexualmedizin in der Praxis"

Springer Medizin

Microdosing Studies in Humans

The Role of Positron Emission Tomography

Abstract

Live-Webinar "Urologie und Sexualmedizin in der Praxis"

Springer Medizin

Abstract

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