TY - JOUR
KW - DILI
KW - DILIference
KW - drug safety
KW - MPS
KW - NAMs
KW - comparative analysis
KW - preclinical model
AU - Shivangi Shrimali
AU - Minjun Chen
AU - Dongying Li
AU - Weida Tong
AB - The 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.
BT - Drug Discovery Today
DA - 2025-08-11
DO - 10.1016/j.drudis.2025.104452
N2 - The 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.
PY - 2025
EP - 104452
ST - New approach methodologies (NAMs) for drug-induced liver injury (DILI)
T2 - Drug Discovery Today
TI - New approach methodologies (NAMs) for drug-induced liver injury (DILI): Where are we now?
UR - https://www.sciencedirect.com/science/article/pii/S1359644625001655
Y2 - 2025-08-18
SN - 1359-6446
ER -