Mass Balance with Radiolabelled Compounds
Mass Balance with Radiolabelled Compounds Services
A radiolabelled human ADME study is conducted to fully determine the routes and rates of elimination (mass balance) of a 14C labelled compound and to characterize the major metabolites in human in order to establish metabolite safety (MIST) by comparing this data with equivalent data from toxicology species. Pharmaron routinely conducts and supports mass balance and metabolism studies and is unique in providing “hybrid” study designs that take advantage of our capabilities to provide both LSC and AMS analytical platforms side-by-side. This flexibility can be particularly valuable for drugs that elicit low systemic exposure.
Pharmaron conducts and supports mass balance and metabolism studies (hAME) employing both low radioactive doses (microtracer <1-5 µCi) and high radioactive doses (macrotracer >50 µCi).
Analysis of metabolites can help inform whether additional DDI evaluation is warranted on specific or “triggered” metabolites. We also offer metabolite scouting and matrix matching with Phase ll/lll clinical samples from repeat dose studies to compare metabolites with those seen in the radioprofiles from the Phase l 14C human metabolism study.
- Total radioactivity in standard matrices (blood, plasma, urine, feces) by LSC and/or AMS
- Total radioactivity in alternative matrices (bile, expired air, PBMCs, dialysate, CSF, vomitus, tissue biopsies)
- Parent drug bioanalysis by LC-MS/MS
- Metabolite profiling by LC-TopCount®, LC-RAD, LC-AMS
- Metabolite identification by HRMS