Use of Physiologically Based Pharmacokinetic Modeling to Evaluate the Effect of Chronic Kidney Disease on the Disposition of Hepatic CYP 2C8 and OATP 1B Drug Substrates

Author:

Tan Ming‐Liang1,Zhao Ping12,Zhang Lei13,Ho Yunn‐Fang4,Varma Manthena V.S.5,Neuhoff Sibylle6,Nolin Thomas D.7ORCID,Galetin Aleksandra8,Huang Shiew‐Mei1

Affiliation:

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. Quantitative SciencesGlobal Health‐Integrated DevelopmentBill and Melinda Gates FoundationSeattleWashingtonUSA

3. Office of Research and Standards Office of Generic Drugs Center for Drug Evaluation and Research US Food and Drug Administration Silver Spring Maryland USA

4. Graduate Institute of Clinical Pharmacy College of Medicine National Taiwan University Taipei Taiwan

5. Pharmacokinetics, Pharmacodynamics & Metabolism Department‐New Chemical Entities Pfizer Inc. Groton Connecticut USA

6. Simcyp Division Certara UK Ltd. Sheffield UK

7. Center for Clinical Pharmaceutical Sciences Department of Pharmacy and Therapeutics, and Department of Medicine Renal‐Electrolyte Division Schools of Pharmacy and Medicine University of Pittsburgh Pittsburgh Pennsylvania USA

8. Centre for Applied Pharmacokinetic Research School of Heath Sciences University of Manchester Manchester UK

Funder

U.S. Department of Energy

U.S. Food and Drug Administration

National Institutes of Health

National Institute of General Medical Sciences

Publisher

Wiley

Subject

Pharmacology (medical),Pharmacology

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