29 July 2008
Microdosing’s big impact
Human microdosing of drugs or other molecules, combined with accelerator mass spectrometry (AMS), can provide fast, reliable clinical data early on in drug development. AMS is able to yield full information on absorption, distribution, metabolism and excretion (ADME) characteristics from microdosing of human volunteers.
Recent data shows that in human microdose tests of 25 molecules, AMS correctly predicted human pharmacokinetics at the pharmacological dose 80% of the time. By improving candidate selection early on, fewer animal tests will be conducted on failing drugs later in the process – saving animals’ lives.
Dr Colin Garner, CEO of Xceleron, a company specialising in human microdosing for drug development said:
“Past studies suggest that in vivo animal models are not necessarily reliable predictors of drug absorption and elimination in humans and we have found human microdosing data to be more than 80% predictive. The benefits of microdosing in terms of cost savings, improved candidate selection, pipeline productivity, and risk mitigation are significant.”
Xceleron co-ordinated the European Union Microdose AMS Partnership Programme (EUMAPP) consortium, an EU-funded project involving 10 organisations from five countries, which culminated in a closing conference in Germany in June this year. At the conference, preliminary results were presented revealing these promising results.
The technique also fits well with the new vision for drug development from the Food and Drug Administration in the USA, which issued guidance in February 2008 stating that it “strongly recommends in vivo metabolic evaluation in humans be performed as early as possible”. The future looks bright for microdosing.