The Role of Liver Biopsy in Drug-Induced Liver Injury

2019 ◽  
Vol 18 (3) ◽  
pp. 287-293
Author(s):  
David E. Kleiner
2020 ◽  
Vol 94 (8) ◽  
pp. 2559-2585 ◽  
Author(s):  
Paul A. Walker ◽  
Stephanie Ryder ◽  
Andrea Lavado ◽  
Clive Dilworth ◽  
Robert J. Riley

Abstract Early identification of toxicity associated with new chemical entities (NCEs) is critical in preventing late-stage drug development attrition. Liver injury remains a leading cause of drug failures in clinical trials and post-approval withdrawals reflecting the poor translation between traditional preclinical animal models and human clinical outcomes. For this reason, preclinical strategies have evolved over recent years to incorporate more sophisticated human in vitro cell-based models with multi-parametric endpoints. This review aims to highlight the evolution of the strategies adopted to improve human hepatotoxicity prediction in drug discovery and compares/contrasts these with recent activities in our lab. The key role of human exposure and hepatic drug uptake transporters (e.g. OATPs, OAT2) is also elaborated.


2020 ◽  
Vol 94 (10) ◽  
pp. 3599-3600
Author(s):  
Tim Brecklinghaus

Sign in / Sign up

Export Citation Format

Share Document