Microdosing for early biokinetic studies in humans

Radiat Prot Dosimetry. 2010 Apr-May;139(1-3):348-52. doi: 10.1093/rpd/ncq029. Epub 2010 Feb 18.

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.

Publication types

  • Research Support, Non-U.S. Gov't

MeSH terms

  • Animals
  • Blood Chemical Analysis / methods*
  • Drug Dosage Calculations*
  • Humans
  • Kinetics
  • Mass Spectrometry / methods*
  • Metabolic Clearance Rate
  • Pharmaceutical Preparations / blood*
  • Pharmacokinetics*

Substances

  • Pharmaceutical Preparations