01390nas a2200253   4500000000100000008004100001260001500042653000900057653001600066653001600082653000800098653000900106653002500115653002200140100002200162700001600184700001600200700001500216245009400231856007200325300001100397520071400408022001401122       2025                            d  c2025-08-1110aDILI10aDILIference10adrug safety10aMPS10aNAMs10acomparative analysis10apreclinical model1 aShivangi Shrimali1 aMinjun Chen1 aDongying Li1 aWeida Tong00aNew approach methodologies (NAMs) for drug-induced liver injury (DILI): Where are we now?  uhttps://www.sciencedirect.com/science/article/pii/S1359644625001655  a1044523 aThe FDA’s ‘Roadmap to Reducing Animal Testing in Preclinical Safety Studies’ supports the regulatory advancement of new approach methodologies (NAMs). Focusing on overlapping drugs, this review compared the performance of in vitro NAMs, animal studies, and microphysiological systems (MPS) in predicting drug-induced liver injury (DILI). We observed considerable variability among in vitro NAMs and potential advantages over animal models. Moreover, limited MPS data hindered meaningful comparison. To enable objective and systematic assessment of NAMs, we propose DILIference, a curated reference drug list compiled from the literature to guide the development and benchmarking of DILI-predictive NAMs.  a1359-6446