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Monitoring for Hepatotoxicity: What Is the Predictive Value of Liver “Function” Tests?

Monitoring for Hepatotoxicity: What Is the Predictive Value of Liver “Function” Tests? Drug‐induced liver injury (DILI) is a major reason drugs fail during development or are withdrawn from the market.1 The ability to predict, detect, and avoid DILI through appropriate patient selection and effective monitoring has proved to be an elusive goal. Many approved drugs have labeling recommendations for serum enzyme monitoring intended to detect and prevent hepatotoxicity, but such monitoring is often seen as inconvenient, uncomfortable, costly, and inefficient by both patients and doctors, and thus monitoring recommendations are poorly followed, if at all. This review considers whether monitoring works to prevent DILI, whether monitoring recommendations are derived from data or opinions, and whether any better alternatives exist. http://www.deepdyve.com/assets/images/DeepDyve-Logo-lg.png Clinical Pharmacology & Therapeutics Wiley

Monitoring for Hepatotoxicity: What Is the Predictive Value of Liver “Function” Tests?

Clinical Pharmacology & Therapeutics , Volume 85 (3) – Mar 1, 2009

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References (31)

Publisher
Wiley
Copyright
© 2009 American Society for Clinical Pharmacology and Therapeutics
ISSN
0009-9236
eISSN
1532-6535
DOI
10.1038/clpt.2008.262
Publisher site
See Article on Publisher Site

Abstract

Drug‐induced liver injury (DILI) is a major reason drugs fail during development or are withdrawn from the market.1 The ability to predict, detect, and avoid DILI through appropriate patient selection and effective monitoring has proved to be an elusive goal. Many approved drugs have labeling recommendations for serum enzyme monitoring intended to detect and prevent hepatotoxicity, but such monitoring is often seen as inconvenient, uncomfortable, costly, and inefficient by both patients and doctors, and thus monitoring recommendations are poorly followed, if at all. This review considers whether monitoring works to prevent DILI, whether monitoring recommendations are derived from data or opinions, and whether any better alternatives exist.

Journal

Clinical Pharmacology & TherapeuticsWiley

Published: Mar 1, 2009

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