scholarly journals Consensus Guidelines: Best Practices for Detection, Assessment and Management of Suspected Acute Drug-Induced Liver Injury During Clinical Trials in Adults with Chronic Viral Hepatitis and Adults with Cirrhosis Secondary to Hepatitis B, C and Nonalcoholic Steatohepatitis

Drug Safety ◽  
2020 ◽  
Author(s):  
William R. Treem ◽  
Melissa Palmer ◽  
Isabelle Lonjon-Domanec ◽  
Daniel Seekins ◽  
Lara Dimick-Santos ◽  
...  
Keyword(s):  
Clinical Trials ◽  
Liver Injury ◽  
Hepatitis B ◽  
Best Practices ◽  
Viral Hepatitis ◽  
Nonalcoholic Steatohepatitis ◽  
Chronic Viral Hepatitis ◽  
Consensus Guidelines ◽  
Drug Induced ◽  
Drug Induced Liver Injury

scholarly journals Assessing Toxicity in Drug Trials in Liver Disease

2021 ◽  
Author(s):  
Morris Sherman
Keyword(s):  
Clinical Trials ◽  
Liver Disease ◽  
Liver Injury ◽  
Viral Hepatitis ◽  
Liver Diseases ◽  
New Drugs ◽  
Drug Trials ◽  
Drug Induced ◽  
Drug Induced Liver Injury

AbstractSince the early trials in viral hepatitis, more and more new drugs are being tested for use in various liver diseases. Since drug hepatotoxicity is a major cause of drugs under investigation not making it to market, the assessment of drug-induced liver injury in clinical trials of new drugs is crucial. This review will focus on the systems that are used to assess drug-induced liver injury in clinical trials and will discuss how some of these criteria are inappropriate or inaccurate in this function together with suggestions for improvement.

scholarly journals Prevention and management of idiosyncratic drug-induced liver injury: Systematic review and meta-analysis of randomised clinical trials

2021 ◽  
Vol 164 ◽  
pp. 105404
Author(s):  
Hao Niu ◽  
Judith Sanabria-Cabrera ◽  
Ismael Alvarez-Alvarez ◽  
Mercedes Robles-Diaz ◽  
Simona Stankevičiūtė ◽  
...  
Keyword(s):  
Systematic Review ◽  
Clinical Trials ◽  
Liver Injury ◽  
Meta Analysis ◽  
Randomised Clinical Trials ◽  
Drug Induced ◽  
Drug Induced Liver Injury

Using controlled clinical trials to learn more about acute drug-induced liver injury

Hepatology ◽  
2008 ◽  
Vol 48 (5) ◽  
pp. 1680-1689 ◽  
Author(s):  
Paul B. Watkins ◽  
Paul J. Seligman ◽  
John S. Pears ◽  
Mark I. Avigan ◽  
John R. Senior
Keyword(s):  
Clinical Trials ◽  
Liver Injury ◽  
Controlled Clinical Trials ◽  
Drug Induced ◽  
Drug Induced Liver Injury
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