Evaluation of Hepatic Impairment Dosing Recommendations in FDA-Approved Product Labels

Author:

Chang Yang1,Burckart Gilbert J.2,Lesko Lawrence J.3,Dowling Thomas C.1

Affiliation:

1. School of Pharmacy; University of Maryland; Baltimore MD USA

2. Office of Clinical Pharmacology, Office of Translational Sciences; Center for Drug Evaluation and Research, U.S. Food and Drug Administration; Silver Spring MD USA

3. Center for Pharmacometrics and Systems Pharmacology; University of Florida College of Pharmacy; Orlando FL USA

Publisher

Wiley

Subject

Pharmacology (medical),Pharmacology

Reference24 articles.

1. Deaths: final data for 2007;Xu;Natl Vital Stat Rep.,2010

2. Changes in the prevalence of the most common causes of chronic liver diseases in the United States from 1988 to 2008;Younossi;Clin Gastroenterol Hepatol.,2011

3. Pharmacokinetics and dosage adjustment in patients with hepatic dysfunction;Verbeeck;Eur J Clin Pharmacol.,2008

4. Dose adjustment in patients with liver disease;Delcò;Drug Saf.,2005

5. U.S. Food and Drug Administration http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/ucm072123.pdf 2012

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