Novel biomarkers for drug-induced liver injury

Author:

Humphries Christopher12,Dear James W.12

Affiliation:

1. Pharmacology, Toxicology and Therapeutics, Centre for Cardiovascular Sciences, University of Edinburgh, The Queens Medical Research Institute, Edinburgh, UK

2. Centre for Precision Cell Therapy for the Liver, Lothian Health Board, Queens Medical Research Institute, Edinburgh, UK

Funder

Centre for Precision Cell Therapy for the Liver

Publisher

Informa UK Limited

Subject

Toxicology,General Medicine

Reference37 articles.

1. Center for Drug Evaluation and Research. Drug-induced liver injury: premarketing clinical evaluation [Internet]. Silver Spring (MD): U.S. Food and Drug Administration (USFDA); 2009. [cited 2023 May 10]. Available from: https://www.fda.gov/regulatory-information/search-fda-guidance-documents/drug-induced-liver-injury-premarketing-clinical-evaluation.

2. FDA-NIH Biomarker Working Group. BEST (biomarkers EndpointS and other tools) resource (Internet). Silver Spring (MD): U.S. Food and Drug Administration (USFDA); 2016–20. Glossary. 2016 Jan 28. Updated 2020 Mar 3. (Webpage)

3. Council for International Organisations of Medical Sciences. Drug-induced liver injury (DILI): current status and future directions for drug development and the post-market setting; 2020.

4. Critical Path Institute (C-Path) Predictive Safety Testing Consortium’s (PSTC) Hepatocyte Working Group (HWG). Qualification plan for glutamate dehydrogenase (GLDH) as a biomarker of drug induced liver injury in individuals with skeletal muscle degeneration; 2020.

5. The past and present of serum aminotransferases and the future of liver injury biomarkers;McGill MR.;EXCLI J,2016

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