Managing the challenge of drug-induced liver injury: a roadmap for the development and deployment of preclinical predictive models

RJ Weaver, EA Blomme, AE Chadwick… - Nature Reviews Drug …, 2020 - nature.com
Drug-induced liver injury (DILI) is a patient-specific, temporal, multifactorial
pathophysiological process that cannot yet be recapitulated in a single in vitro model …

Liver microphysiological systems development guidelines for safety risk assessment in the pharmaceutical industry

AR Baudy, MA Otieno, P Hewitt, J Gan, A Roth… - Lab on a Chip, 2020 - pubs.rsc.org
The liver is critical to consider during drug development because of its central role in the
handling of xenobiotics, a process which often leads to localized and/or downstream tissue …

Comparison of hepatic 2D sandwich cultures and 3D spheroids for long-term toxicity applications: a multicenter study

CC Bell, ACA Dankers, VM Lauschke… - Toxicological …, 2018 - academic.oup.com
Primary human hepatocytes (PHHs) are commonly used for in vitro studies of drug-induced
liver injury. However, when cultured as 2D monolayers, PHH lose crucial hepatic functions …

Today's challenges to de-risk and predict drug safety in human “mind-the-gap”

RJ Weaver, JP Valentin - Toxicological Sciences, 2019 - academic.oup.com
Current gaps in drug safety sciences can result from the inability (1) to identify hazard across
multiple target organs,(2) to predict and risk assess with certainty against drug safety …

Integrated in vitro models for hepatic safety and metabolism: evaluation of a human Liver-Chip and liver spheroid

AJ Foster, B Chouhan, SL Regan, H Rollison… - Archives of …, 2019 - Springer
Drug-induced liver injury remains a frequent reason for drug withdrawal. Accordingly, more
predictive and translational models are required to assess human hepatotoxicity risk. This …

Safety data and withdrawal of hepatotoxic drugs

S Babai, L Auclert, H Le-Louët - Therapies, 2021 - Elsevier
Background and aim The occurrence of drug induced liver injury (DILI) is the most common
reason of post-marketing withdrawals. DILI in humans is difficult to predict using in vitro …

In vitro models for studying chronic drug-induced liver injury

MT Donato, G Gallego-Ferrer, L Tolosa - International Journal of …, 2022 - mdpi.com
Drug-induced liver injury (DILI) is a major clinical problem in terms of patient morbidity and
mortality, cost to healthcare systems and failure of the development of new drugs. The need …

Bioprinting of human liver‐derived epithelial organoids for toxicity studies

MC Bouwmeester, PN Bernal… - Macromolecular …, 2021 - Wiley Online Library
There is a need for long‐lived hepatic in vitro models to better predict drug induced liver
injury (DILI). Human liver‐derived epithelial organoids are a promising cell source for …

3D human tissue models and microphysiological systems for HIV and related comorbidities

DE Yin, AC Palin, TB Lombo, RN Mahon, B Poon… - Trends in …, 2023 - cell.com
Abstract Three-dimensional (3D) human tissue models/microphysiological systems (eg,
organs-on-chips, organoids, and tissue explants) model HIV and related comorbidities and …

High-content screening for the detection of drug-induced oxidative stress in liver cells

MT Donato, L Tolosa - Antioxidants, 2021 - mdpi.com
Drug-induced liver injury (DILI) remains a major cause of drug development failure, post-
marketing warnings and restriction of use. An improved understanding of the mechanisms …