Liver toxicity in oncology trials and beyond: a simplified concept for management of hepatocellular drug-induced liver injury in patients with abnormal baseline liver tests

Author:

Merz Michael12ORCID,Fettiplace Anna3,Marcinak John4,Tillmann Hans L.5,Rockey Don C.6,Kullak-Ublick Gerd A.27

Affiliation:

1. Michael Merz Consulting, Freiburg, Germany

2. Mechanistic Safety, Patient Safety and Pharmacovigilance, Global Drug Development, Novartis, Basel, Switzerland

3. Fettiplace Consulting Ltd, Letchworth Garden City, UK

4. Medical Safety Evaluation, Pharmacovigilance and Patient Safety, AbbVie, North Chicago, IL, USA

5. Division Gastroenterology, Hepatology & Nutrition, Department of Medicine, East Carolina University, Greenville, NC, USA

6. Digestive Disease Research Center, Medical University of South Carolina, Charleston, SC, USA

7. Department of Clinical Pharmacology and Toxicology, University Hospital Zurich, University of Zurich, Zurich, Switzerland

Publisher

Informa UK Limited

Reference35 articles.

1. Idiosyncratic Drug-Induced Liver Injury Is Associated With Substantial Morbidity and Mortality Within 6 Months From Onset

2. Drug-induced acute liver failure

3. Drug-Induced Hepatotoxicity

4. Drug-induced Acute Liver Failure

5. U.S. Department of health and human services FDA Center for Drug Evaluation and Research (CDER) Center for Biologics Evaluation and Research (CBER). Guidance For Industry. Drug-Induced Liver Injury: Premarketing Clinical Evaluation. 2009 [cited 2022 Jan 20]. Available from: https://www.fda.gov/media/116737/download

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