New Approach Methodologies ( NAMs ): Guiding Clinical Predictions through Human‐Relevant Evidence

New Approach Methodologies (NAMs) encompass a growing family of non-animal and human-relevant tools designed to reduce, refine or replace traditional animal studies while generating evidence that is more translatable to human biology. 1 However, NAMs are still often framed as alternatives to conventional animal studies.This framing understates their broader and potentially more significant role in drug development.The more pertinent question is not simply 'If a method is nonanimal or technologically novel?'.It is whether the method can generate human-relevant evidence, demonstrate sufficient credibility for its intended use and support informed regulatory decisions.This broader vision motivated the Clinical Pharmacology & Therapeutics themed issue, 'New Approach Methodologies (NAMs): Guiding Clinical Predictions through Humanrelevant Evidence' .Numerous articles in this issue illustrate the translational utility of NAMs across the drug development continuum.Together, they also show that experimental and computational NAMs are not competing but complementary components of translational pharmacology.Experimental NAMs generate human-relevant biological data.Computational NAMs integrate these data into the context of whole-body exposure, disease and population variability to generate quantitative predictions.2 This interdependence is critical for improving the translation of safety and efficacy findings across drug development.