Microdosing for early biokinetic studies in humans.
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.
Stenström
K
K
Department of Physics, Division of Nuclear Physics, Lund University, PO Box 118, SE-221 00 Lund, Sweden. kristina.stenstrom@nuclear.lu.se
Sydoff
M
M
Mattsson
S
S
D000818:Animals; D001774:Blood Chemical Analysis / Q000379:methods*; D054796:Drug Dosage Calculations; D006801:Humans; D007700:Kinetics; D013058:Mass Spectrometry / Q000379:methods*; D008657:Metabolic Clearance Rate; D004364:Pharmaceutical Preparations / Q000097:blood*; D010599:Pharmacokinetics
D004364:Pharmaceutical Preparations