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