Utility of a physiologically-based pharmacokinetic (PBPK) modeling approach to quantitatively predict a complex drug-drug-disease interaction scenario for rivaroxaban during the drug review process: implications for clinical practice-Reference-Cited by-同舟云学术

Utility of a physiologically-based pharmacokinetic (PBPK) modeling approach to quantitatively predict a complex drug-drug-disease interaction scenario for rivaroxaban during the drug review process: implications for clinical practice

Published:2012-03 Issue:2 Volume:33 Page:99-110
ISSN:0142-2782
Container-title:Biopharmaceutics & Drug Disposition
language:en
Short-container-title:Biopharm. Drug Dispos.

Author:

Grillo Joseph A.¹,Zhao Ping¹,Bullock Julie¹,Booth Brian P.¹,Lu Min²,Robie-Suh Kathy²,Berglund Eva Gil³,Pang K. Sandy⁴,Rahman Atiqur¹,Zhang Lei¹,Lesko Lawrence J.¹,Huang Shiew-Mei¹

Affiliation:

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

2. Division of Hematology Products (DHP), Center for Drug Evaluation and Research; U.S. Food and Drug Administration; Silver Spring; MD; USA

3. Medical Products Agency; Uppsala; Sweden

4. Leslie Dan Faculty of Pharmacy, University of Toronto; Canada

Publisher

Wiley

Subject

Pharmacology (medical),Pharmaceutical Science,Pharmacology,General Medicine

Link

http://onlinelibrary.wiley.com/wol1/doi/10.1002/bdd.1771/fullpdf

Reference41 articles.

1. Janssen Pharmaceuticals, Inc XARELTO® (rivaroxaban) package insert 2011 http://www.xareltohcp.com/xarelto-prescribing-information.html

2. US FDA Approval History, NDA 022406 Xarelto (rivaroxaban) 10 mg immediate release Tablets http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/022406s000ltr.pdf http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/022406s000ltr.pdf

3. European Medicines Agency Summary of Product Characteristics or SPC: Xarelto www.ema.europa.eu/docs/en_GB/document_library/EPAR_-_Product_Information/human/000944/WC500057108

4. European Medicines Agency CHMP Assessment Report: Xarelto www.ema.europa.eu/docs/en_GB/document_library/EPAR_-_Public_assessment_report/human/000944/WC500057122

5. Safety, pharmacodynamics, and pharmacokinetics of BAY 59-7939 - an oral, direct Factor Xa inhibitor - after multiple dosing in healthy male subjects;Kubitza;Eur J Clin Pharmacol,2005

Cited by 84 articles. 订阅此论文施引文献订阅此论文施引文献，注册后可以免费订阅5篇论文的施引文献，订阅后可以查看论文全部施引文献

1. In Vitro Assessment of Inhibitory Effects of Kinase Inhibitors on CYP2C9, 3A and 1A2: Prediction of Drug-Drug Interaction Risk with Warfarin and Direct Oral Anticoagulants;European Journal of Pharmaceutical Sciences;2024-08

2. Simulating Healthy Participant Pharmacokinetics for Renal and Hepatic Impairment Studies: Retrospective Assessment of the Approach;The AAPS Journal;2024-06-06

3. Apixaban and rivaroxaban's physiologically‐based pharmacokinetic model validation in hospitalized patients: A first step for larger use of a priori modeling approach at bed side;CPT: Pharmacometrics & Systems Pharmacology;2023-10-04

4. Understanding Statin‐Roxadustat Drug–Drug‐Disease Interaction Using Physiologically‐Based Pharmacokinetic Modeling;Clinical Pharmacology & Therapeutics;2023-07-13

5. Coming full circle: The potential utility of real‐world evidence to discern predictions from a physiologically based pharmacokinetic model;Biopharmaceutics & Drug Disposition;2023-06-22