01519nas a2200217 4500000000100000008004100001260001500042653000700057653001800064653002800082653001800110653002300128100002200151700002000173245008000193856004700273300000800320490000700328520095200335022001401287 2025 d c2025-02-0410a3R10aAnimal ethics10aEvidence-Based Medicine10aMurine models10aPrecision Medicine1 aHamideh Frühwein1 aNorbert W. Paul00a“Lost in translation?” Animal research in the era of precision medicine uhttps://doi.org/10.1186/s12967-025-06084-3 a1520 v233 aPreclinical animal research has long been a cornerstone in evaluating the efficacy, toxicity, and safety of potential drug treatments before they proceed to human clinical trials. However, given the intricate nature of human physiology and the complexities of diseases such as cancer, this paper critically examines the role of animal experimentation in translational research, both from epistemological and ethical viewpoints. We argue that the ethical obligation to protect animals extends beyond their instrumental value for human benefit; it is rooted in the intrinsic value of their well-being. Consequently, we advocate for a paradigm shift in medical research: the adoption of new approach methodologies (NAMs) not merely as supplementary tools but as complete replacements for animal use in medical studies. In this context, replacement emerges as the key principle—an imperative that should be prioritized over all other considerations. a1479-5876