NAMs in DMPK: Case studies and context-of-use applications

ISSX 2025 -- On April 10, 2025, the FDA announced the publication of a roadmap to reduce animal testing in preclinical safety studies. This ambitious initiative builds upon global regulatory agency momentum, and governmental and societal desire to phase in new approach methodology (NAM) alternatives, as animal studies are phased out. NAMs are not a new concept, and have been used for many years within drug metabolism and pharmacokinetics (DMPK), across pharmaceutical and chemicals sectors for early decision making, and especially in the early compound discovery or lead optimisation phases during the drug development paradigm.