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 …
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
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 …
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 …
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 …
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 …
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 …
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 …
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 …
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 …
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 …
marketing warnings and restriction of use. An improved understanding of the mechanisms …