Drug-Induced Liver Injury in Patients With Preexisting Chronic Liver Disease in Drug Development: How to Identify and Manage?

Author:

Chalasani Naga,Regev Arie

Publisher

Elsevier BV

Subject

Gastroenterology,Hepatology

Reference26 articles.

1. Food and Drug Administration. Drug-induced livery injury: premarketing clinical evaluation. In: Guidance for industry. 2009. Available: www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM174090.pdf. Accessed August 1, 2016.

2. Health Canada. Guidance document: pre-market evaluation of hepatotoxicity in health products. 2012. Available: www.hc-sc.gc.ca/dhp-mps/prodpharma/applic-demande/guide-ld/hepatotox_guide_ld-eng.php. Accessed August 1, 2016.

3. Using controlled clinical trials to learn more about acute drug-induced liver injury;Watkins;Hepatology,2008

4. Case definition and phenotype standardization in drug-induced liver injury;Aithal;Clin Pharmacol Ther,2011

5. Causality assessment for suspected DILI during clinical phases of drug development;Regev;Drug Safety,2014

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