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869-The Human-Centric Evolution of Drug Discovery NAMs

This paper explores the transformative shift in drug discovery from traditional animal-based modeling toward human-centric New Approach Methodologies (NAMs). This evolution is driven by high clinical failure rates and is supported by updated regulatory frameworks from the FDA and NIH that no longer mandate animal testing. The review categorizes these innovations into stem cell-based, organoid-based, and in silico (AI) platforms, detailing how they replicate complex human physiology more accurately than animal models. These technologies span the entire drug development continuum, facilitating…

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