Assessing Pharmacokinetics in Liver Disease: Challenges and Future Considerations for Classification of Hepatic Dysfunction and Use of In Silico Methods
1 Office of Clinical Pharmacology, Office of Translational Sciences, Center for Drug Evaluation and Research, US Food and Drug Administration, Silver Spring, Maryland, USA.
2 Division of Hepatology and Nutrition, Office of New Drugs, Center for Drug Evaluation and Research, US Food and Drug Administration, Silver Spring, Maryland, USA.
3 Center for Translational Medicine, School of Pharmacy, University of Maryland, Baltimore, Maryland, USA.