Metabolite Profiling of Radiolabelled Compounds
Metabolite Profiling of Radiolabelled Compounds Services
Pharmaron’s mass spectroscopy and biotransformation experts provide an in-depth assessment of metabolites to compare clinical and non-clinical metabolic pathways, comparative analysis and structure elucidation. Metabolite profiling and identification is a key component of any radiolabelled metabolism study to profile, quantify and identify all major metabolites formed in the body (and sometimes minor metabolites) to establish metabolite safety and accurately identify any disproportionate metabolites seen in human.
- Comparative analysis of metabolites –profiling and identification of metabolites seen from in vitro (typically hepatocytes), animal ADME and human metabolism studies
- Metabolic profiling and MetID by combining fractionation with flow-through radio-detection (or fraction collection with LSC/AMS quantitation) and structure elucidation of metabolites using high resolution LC-MS/MS instruments with accurate mass
- Extrapolation of metabolite data between radiolabelled and non-radiolabelled samples by scouting for the same metabolites in clinical trials that were quantified and identified in the radiolabelled study
- In-house synthesis of metabolite reference standards and stable 13C labels
- Metabolism/catabolism investigations for large molecules and biologics using 3H and 14C radiolabels
Capabilities
Performed in Accordance with FDA Regulatory Guidelines
- FDA ‘Safety Testing of Drug Metabolites’ – Guidance for Industry (November 2016)
- ‘Metabolites in Safety Testing’ (MIST) PhRMA Position Paper (April 2016)
