Human Metabolism Studies
Pharmaron offers integrated clinical metabolism studies to assist our partners with a complete metabolism strategy to fast-track drug development and regulatory approvals.
Pharmaron is unique in being able to conduct human studies with ultra-low doses of radioactivity by taking advantage of our Accelerator Mass Spectrometry (AMS) platform for the analysis of carbon-14 (14C) microtracers. Integrated clinical metabolism services include designing and executing clinical protocols, manufacturing and/or repurifying clinical grade 14C material, formulation and preparation of 14C drug product, AMS and/or LSC analysis of clinical samples, LC/MS/MS based bioanalysis, metabolite profiling/ID and DDI.
Pharmaron’s facilities in Maryland, USA (Clinical Pharmacology Center/CPC and Advanced Bioanalytical Sciences/ABS) and Rushden, UK (clinical metabolism lab) work closely together to conduct integrated radiolabelled human clinical metabolism studies with 14C. These essential clinical programs assess the metabolism, excretion and pharmacokinetics of our partners’ drug candidates and are necessary to advance the development and marketing approval of novel therapeutics.