Accelerated Carbon-14 Clinical Programs Services

Pharmaron’s Accelerator Mass Spectrometry (AMS) team assists our partners to improve the efficiency of their R&D programs using state-of-the-art ¹⁴C-AMS technology. Our extensive experience and history with AMS technology not only helps reduce development times, but often provides critical metabolism data and resolves questions on metabolites that cannot be answered in any other way. This is especially true for potent compounds with low systemic exposures and drugs or metabolites with long elimination half-lives. Pharmaron’s AMS platform helps support both clinical and non-clinical programs to assess ADME parameters in addition to tissue disposition and PK. AMS is also helpful to determine absolute bioavailability employing IV ¹⁴C microtracers. All AMS-enabled clinical studies under GCP are fully acceptable and submissible to the regulatory authorities (FDA, EMA, MHRA, JMHW, TSA) as the definitive data to characterize mass balance, rates and routes of excretion, metabolite safety (MIST) and/or absolute bioavailability.

AMS Method Development

• Analytical method development and validation is typically not on the critical path for AMS assays as the analyte for AMS is ¹⁴C atoms and lower limits of quantitation (LLOQ) can be pre-determined mathematically
• AMS methods are independent of matrix effects and chemical structure, and unlike LC-MS/MS, are not affected by molecules that ionize poorly or lack chromophores
• AMS generates very rich data sets incorporating quantification of all drug-derived material (total radioactivity), specific analytes (parent compounds and/or metabolites of interest) and fully quantitative, ultra-high resolution metabolite profiles