Work

Human Radiolabeled Mass Balance Studies Supporting New Drugs Approved by FDA Between 2019 and 2023

Year: 2026

Type: article

Abstract: Human radiolabeled mass balance studies are essential for understanding the absorption, distribution, metabolism, and excretion (ADME) of investigational drugs.The Food and Drug Administration (FDA) guidance recommends conducting these studies for new molecular entities (NMEs) to inform drug development programs.Herein, we analyzed new drug applications (NDAs) approved between 2019-2023, and results showed continued alignment with previous 2014-2018 findings and with recommendations in the FDA guidance.These studies remain foundational to drug development but are evolving to incorporate scientific innovations.

Source: Clinical and Translational Science

DOI: 10.1111/cts.70679