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. 2018 Oct 26;105(3):719–729. doi: 10.1002/cpt.1205

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© 2018 The Authors. Clinical Pharmacology & Therapeutics published by Wiley Periodicals LLC on behalf of American Society for Clinical Pharmacology and Therapeutics. This article has been contributed to by US Government employees and their work is in the public domain in the USA.

This is an open access article under the terms of the http://creativecommons.org/licenses/by-nc-nd/4.0/ 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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Workflow of physiologically based pharmacokinetic (PBPK) modeling and simulations. The adopted base PBPK models were verified using clinical drug‐drug interaction (DDI) and pharmacogenetic (PGx) studies in a healthy volunteer (HV) population. The verified models were applied to Simcyp Simulator V16 default and modified severe chronic kidney disease (CKD) populations for: (i) cytochrome P450 (CYP)2C8 substrates rosiglitazone and pioglitazone; (ii) organic anion‐transporting polypeptide (OATP)1B substrate pitavastatin; and (iii) CYP2C8/OATP1B dual substrate repaglinide. The CYP2C8 and OATP1B activities were optimized to recover clinical observations.