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