Microdosing for early biokinetic studies in humans.
K Stenström, M Sydoff, S Mattsson
Radiation protection dosimetry 2010 DOI: 10.1093/rpd/ncq029 (opens in new tab)
Study at a glance
AI-extracted from the abstract| Characteristics | Review Peer reviewed |
|---|---|
| Topics | Microdosing |
| Key findings | Argues that microdosing with AMS may improve candidate selection, reduce failure rates, and lower costs in drug development, while also decreasing animal use in early testing. |
Abstract
Microdosing is a new concept in drug development that--if implemented in the pharmaceutical industry--would mean that new drugs can be tested earlier in humans than done today. The human microdosing concept--or 'Phase 0'--may offer improved candidate selection, reduced failure rates in the drug development line and a reduction in the use of laboratory animals in early drug development, factors which will help to speed up drug development and also reduce the costs. Microdosing utilises sub-pharmacological amounts of the substance to open opportunities for early studies in man. Three technologies are used for microdosing: accelerator mass spectrometry (AMS), positron emission tomography and liquid chromatography-tandem mass spectrometry. This paper focuses on the principle of AMS and discusses the current status of microdosing with AMS.
Comparable studies
Other narrative reviews on microdosing, most cited first.
| Study | Year | Design | Participants |
|---|---|---|---|
| Big physics, small doses: the use of AMS and PET in human microdosing of development drugs | 2003 | Review | |
| Phase 0/microdosing approaches: time for mainstream application in drug development? | 2020 | Review | |
| Microdosing and drug development: past, present and future | 2013 | Review | |
| Microdosing and Other Phase 0 Clinical Trials: Facilitating Translation in Drug Development | 2016 | Review | |
| Expectancy Effects in Psychedelic Trials. | 2024 | Review |