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. 2016 Oct 15;9(6):328–336. doi: 10.1111/cts.12421

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© 2016 The Authors. Clinical and Translational Science published by Wiley Periodicals, Inc. on behalf of American Society for Clinical Pharmacology and Therapeutics

This is an open access article under the terms of the Creative Commons Attribution‐NonCommercial‐NoDerivs License, which permits use and distribution in any medium, provided the original work is properly cited, the use is non‐commercial and no modifications or adaptations are made.

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Plasma OCA Concentrations are a Poor Surrogate for Liver OCA Concentrations. Systemic exposure of OCA was predicted to be 1.4‐, 8.0‐, and 13‐fold greater in subjects with mild, moderate, and severe hepatic impairment, respectively, based on Child‐Pugh score, than in healthy volunteers, which is consistent with the observed results. Liver exposure of OCA was predicted to be 1.1‐, 1.5‐, and 1.7‐fold greater in subjects with mild, moderate, and severe hepatic impairment, respectively, than in healthy volunteers. n = 8 for observed values. Predicted values were estimated using a 200 replicate simulation from the physiologic pharmacokinetic model of OCA (n = 1,600). Boxplot whiskers represent 1st to 99th percentile.