Mass Balance Using AMS

Administration of a 14C microtracer drug dose combined with a full therapeutic drug dose provides clinical mass balance and metabolism data faster than conventional high 14C dose studies. 

We can accelerate timelines whenever the dose of 14C-drug is sufficiently low to preclude the need for dosimetry or full GMP manufactured 14C-API. Our clients typically employ the 14C microtracer approach for human ADME when presented with radiological safety concerns or PK criteria, such as:

  • Drug has a long elimination half-life in human and/or is slowly excreted
  • Drug accumulates in sensitive tissues (i.e. eye, melanin)
  • Drug forms a major metabolite with a much longer elimination half-life than parent compound
  • Study conducted in sensitive populations
  • 14C-API is unstable due to autoradiolysis

Our expert team provides:

  • Clinical study design consultation (for healthy or patient volunteers)
  • All sample preparation for total radioactivity analysis, including homogenization and freeze-drying,
  • Quantitation of total 14C by AMS (or LSC) in blood, plasma, urine, feces, expired air and other matrices as required
  • Metabolite analysis - Metabolite Profiling

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