Achieving FDA Drug Approval
Client success is the top priority for every project we take on, with the ultimate measure of success often being FDA drug approval. Pharmaron’s radiolabelled sciences division supports compound development from non-clinical studies to clinical trials, enabling partners to reach critical development milestones and achieve successful compound registration.
A 2016 client study, published in Drug Metabolism & Disposition, focused on AstraZeneca’s small molecule kinase inhibitor, AZD-9291 (osimertinib), a non-small cell lung cancer treatment. The human metabolism study used Pharmaron’s Accelerator Mass Spectrometry (AMS) technology (mass balance and metabolite profiling). This contributed to the speedy clinical development and FDA approval of the drug now marketed as TAGRISSO®.
Drug Metab Dispos, 44:1201-1212, August 2016
Written with permission by AstraZeneca
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