{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,7,28]],"date-time":"2026-07-28T07:12:49Z","timestamp":1785222769849,"version":"3.55.0"},"reference-count":43,"publisher":"Elsevier BV","issue":"4","license":[{"start":{"date-parts":[[2017,4,1]],"date-time":"2017-04-01T00:00:00Z","timestamp":1491004800000},"content-version":"tdm","delay-in-days":0,"URL":"https:\/\/www.elsevier.com\/tdm\/userlicense\/1.0\/"},{"start":{"date-parts":[[2017,4,1]],"date-time":"2017-04-01T00:00:00Z","timestamp":1491004800000},"content-version":"tdm","delay-in-days":0,"URL":"https:\/\/www.elsevier.com\/legal\/tdmrep-license"}],"content-domain":{"domain":["dmd.aspetjournals.org","elsevier.com","sciencedirect.com"],"crossmark-restriction":true},"short-container-title":["Drug Metabolism and Disposition"],"published-print":{"date-parts":[[2017,4]]},"DOI":"10.1124\/dmd.116.074450","type":"journal-article","created":{"date-parts":[[2017,2,7]],"date-time":"2017-02-07T01:25:18Z","timestamp":1486430718000},"page":"390-398","update-policy":"https:\/\/doi.org\/10.1016\/elsevier_cm_policy","source":"Crossref","is-referenced-by-count":37,"title":["Application of Physiologically Based Pharmacokinetic Modeling to the Understanding of Bosutinib Pharmacokinetics: Prediction of Drug\u2013Drug and Drug\u2013Disease Interactions"],"prefix":"10.1016","volume":"45","author":[{"given":"Chiho","family":"Ono","sequence":"first","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Poe-Hirr","family":"Hsyu","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Richat","family":"Abbas","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Cho-Ming","family":"Loi","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Shinji","family":"Yamazaki","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"78","reference":[{"key":"10.1124\/dmd.116.074450_bib1","doi-asserted-by":"crossref","first-page":"57","DOI":"10.1515\/dmdi-2014-0026","article-title":"Effect of rifampin on the pharmacokinetics of bosutinib, a dual Src\/Abl tyrosine kinase inhibitor, when administered concomitantly to healthy subjects","volume":"30","author":"Abbas","year":"2015","journal-title":"Drug Metab Pers Ther"},{"key":"10.1124\/dmd.116.074450_bib2","doi-asserted-by":"crossref","first-page":"123","DOI":"10.1007\/s00280-012-1987-7","article-title":"Evaluation of the pharmacokinetics and safety of bosutinib in patients with chronic hepatic impairment and matched healthy subjects","volume":"71","author":"Abbas","year":"2013","journal-title":"Cancer Chemother Pharmacol"},{"key":"10.1124\/dmd.116.074450_bib3","doi-asserted-by":"crossref","first-page":"1191","DOI":"10.1007\/s40262-016-0391-6","article-title":"Clinical pharmacokinetics and pharmacodynamics of bosutinib","volume":"55","author":"Abbas","year":"2016","journal-title":"Clin Pharmacokinet"},{"key":"10.1124\/dmd.116.074450_bib4","doi-asserted-by":"crossref","first-page":"E304","DOI":"10.1002\/ijc.27348","article-title":"A randomized, crossover, placebo- and moxifloxacin-controlled study to evaluate the effects of bosutinib (SKI-606), a dual Src\/Abl tyrosine kinase inhibitor, on cardiac repolarization in healthy adult subjects","volume":"131","author":"Abbas","year":"2012","journal-title":"Int J Cancer"},{"key":"10.1124\/dmd.116.074450_bib5","doi-asserted-by":"crossref","DOI":"10.1016\/j.clinthera.2012.07.006","article-title":"Ascending single-dose study of the safety profile, tolerability, and pharmacokinetics of bosutinib coadministered with ketoconazole to healthy adult subjects","volume":"34","author":"Abbas","year":"2012","journal-title":"Clin Ther"},{"key":"10.1124\/dmd.116.074450_bib6","doi-asserted-by":"crossref","first-page":"8341","DOI":"10.1158\/1078-0432.CCR-04-1371","article-title":"Factors affecting cytochrome P-450 3A activity in cancer patients","volume":"10","author":"Baker","year":"2004","journal-title":"Clin Cancer Res"},{"key":"10.1124\/dmd.116.074450_bib7","doi-asserted-by":"crossref","first-page":"962","DOI":"10.1002\/jcph.128","article-title":"Evaluation of hepatic impairment dosing recommendations in FDA-approved product labels","volume":"53","author":"Chang","year":"2013","journal-title":"J Clin Pharmacol"},{"key":"10.1124\/dmd.116.074450_bib8","doi-asserted-by":"crossref","first-page":"141","DOI":"10.1002\/bdd.1830","article-title":"A physiologically based pharmacokinetic (PBPK) approach to evaluate pharmacokinetics in patients with cancer","volume":"34","author":"Cheeti","year":"2013","journal-title":"Biopharm Drug Dispos"},{"key":"10.1124\/dmd.116.074450_bib9","doi-asserted-by":"crossref","first-page":"4567","DOI":"10.1182\/blood-2011-05-355594","article-title":"Safety and efficacy of bosutinib (SKI-606) in chronic phase Philadelphia chromosome-positive chronic myeloid leukemia patients with resistance or intolerance to imatinib","volume":"118","author":"Cortes","year":"2011","journal-title":"Blood"},{"key":"10.1124\/dmd.116.074450_bib10","doi-asserted-by":"crossref","first-page":"1092","DOI":"10.1158\/1078-0432.CCR-11-2378","article-title":"Phase I study of bosutinib, a Src\/Abl tyrosine kinase inhibitor, administered to patients with advanced solid tumors","volume":"18","author":"Daud","year":"2012","journal-title":"Clin Cancer Res"},{"key":"10.1124\/dmd.116.074450_bib11","doi-asserted-by":"crossref","first-page":"1065","DOI":"10.1517\/17425255.4.8.1065","article-title":"The effect of chronic renal failure on drug metabolism and transport","volume":"4","author":"Dreisbach","year":"2008","journal-title":"Expert Opin Drug Metab Toxicol"},{"key":"10.1124\/dmd.116.074450_bib12","doi-asserted-by":"crossref","first-page":"157","DOI":"10.2174\/1389200043489054","article-title":"The effect of liver cirrhosis on the regulation and expression of drug metabolizing enzymes","volume":"5","author":"Elbekai","year":"2004","journal-title":"Curr Drug Metab"},{"key":"10.1124\/dmd.116.074450_bib13","unstructured":"Foti RS (2014) Strategies and retrospective data analysis in hepatic impairment studies, in Proceedings of the 19th North American Regional ISSX Meeting; 2014 Oct 19\u201323; San Francisco, CA. International Society for the Study of Xenobiotics, Washington, DC."},{"key":"10.1124\/dmd.116.074450_bib14","doi-asserted-by":"crossref","first-page":"513","DOI":"10.1177\/0091270009333209","article-title":"Prediction of human pharmacokinetics from preclinical information: comparative accuracy of quantitative prediction approaches","volume":"49","author":"Hosea","year":"2009","journal-title":"J Clin Pharmacol"},{"key":"10.1124\/dmd.116.074450_bib15","doi-asserted-by":"crossref","first-page":"441","DOI":"10.2133\/dmpk.DMPK-13-RG-126","article-title":"Population pharmacokinetic and pharmacodynamic analysis of bosutinib","volume":"29","author":"Hsyu","year":"2014","journal-title":"Drug Metab Pharmacokinet"},{"key":"10.1124\/dmd.116.074450_bib16","doi-asserted-by":"crossref","first-page":"49","DOI":"10.1007\/s00228-016-2108-z","article-title":"Effect of aprepitant, a moderate CYP3A4 inhibitor, on bosutinib exposure in healthy subjects","volume":"73","author":"Hsyu","year":"2017","journal-title":"Eur J Clin Pharmacol"},{"key":"10.1124\/dmd.116.074450_bib17","doi-asserted-by":"crossref","first-page":"2912","DOI":"10.1002\/jps.23570","article-title":"The utility of modeling and simulation in drug development and regulatory review","volume":"102","author":"Huang","year":"2013","journal-title":"J Pharm Sci"},{"key":"10.1124\/dmd.116.074450_bib18","doi-asserted-by":"crossref","first-page":"542","DOI":"10.1038\/clpt.2011.320","article-title":"The role of physiologically based pharmacokinetic modeling in regulatory review","volume":"91","author":"Huang","year":"2012","journal-title":"Clin Pharmacol Ther"},{"key":"10.1124\/dmd.116.074450_bib19","doi-asserted-by":"crossref","first-page":"211","DOI":"10.1517\/17425250802691074","article-title":"The Simcyp population-based ADME simulator","volume":"5","author":"Jamei","year":"2009","journal-title":"Expert Opin Drug Metab Toxicol"},{"key":"10.1124\/dmd.116.074450_bib20","doi-asserted-by":"crossref","first-page":"189","DOI":"10.2165\/11318160-000000000-00000","article-title":"A semi-mechanistic model to predict the effects of liver cirrhosis on drug clearance","volume":"49","author":"Johnson","year":"2010","journal-title":"Clin Pharmacokinet"},{"key":"10.1124\/dmd.116.074450_bib21","doi-asserted-by":"crossref","first-page":"e63","DOI":"10.1038\/psp.2013.41","article-title":"Basic concepts in physiologically based pharmacokinetic modeling in drug discovery and development","volume":"2","author":"Jones","year":"2013","journal-title":"CPT Pharmacometrics Syst Pharmacol"},{"key":"10.1124\/dmd.116.074450_bib22","doi-asserted-by":"crossref","first-page":"247","DOI":"10.1002\/cpt.37","article-title":"Physiologically based pharmacokinetic modeling in drug discovery and development: a pharmaceutical industry perspective","volume":"97","author":"Jones","year":"2015","journal-title":"Clin Pharmacol Ther"},{"key":"10.1124\/dmd.116.074450_bib23","doi-asserted-by":"crossref","first-page":"1295","DOI":"10.1080\/00498250701534885","article-title":"Challenges and opportunities with modelling and simulation in drug discovery and drug development","volume":"37","author":"Lav\u00e9","year":"2007","journal-title":"Xenobiotica"},{"key":"10.1124\/dmd.116.074450_bib24","doi-asserted-by":"crossref","first-page":"235","DOI":"10.1517\/17425255.3.2.235","article-title":"Whole-body physiologically based pharmacokinetic models","volume":"3","author":"Nestorov","year":"2007","journal-title":"Expert Opin Drug Metab Toxicol"},{"key":"10.1124\/dmd.116.074450_bib25","unstructured":"Pfizer (2016) Prescribing information for Bosulif (bosutinib) tablets, for oral use. Pfizer, New York."},{"key":"10.1124\/dmd.116.074450_bib26","doi-asserted-by":"crossref","first-page":"629","DOI":"10.1208\/s12248-013-9470-x","article-title":"Drug-drug interaction studies: regulatory guidance and an industry perspective","volume":"15","author":"Prueksaritanont","year":"2013","journal-title":"AAPS J"},{"key":"10.1124\/dmd.116.074450_bib27","doi-asserted-by":"crossref","first-page":"646","DOI":"10.1002\/bjs.1800600817","article-title":"Transection of the oesophagus for bleeding oesophageal varices","volume":"60","author":"Pugh","year":"1973","journal-title":"Br J Surg"},{"key":"10.1124\/dmd.116.074450_bib28","doi-asserted-by":"crossref","first-page":"1259","DOI":"10.1002\/jps.20322","article-title":"Physiologically based pharmacokinetic modeling 1: predicting the tissue distribution of moderate-to-strong bases","volume":"94","author":"Rodgers","year":"2005","journal-title":"J Pharm Sci"},{"key":"10.1124\/dmd.116.074450_bib29","doi-asserted-by":"crossref","first-page":"45","DOI":"10.1146\/annurev-pharmtox-010510-100540","article-title":"Physiologically-based pharmacokinetics in drug development and regulatory science","volume":"51","author":"Rowland","year":"2011","journal-title":"Annu Rev Pharmacol Toxicol"},{"key":"10.1124\/dmd.116.074450_bib30","doi-asserted-by":"crossref","first-page":"261","DOI":"10.1586\/ecp.10.143","article-title":"Modeling and predicting drug pharmacokinetics in patients with renal impairment","volume":"4","author":"Rowland Yeo","year":"2011","journal-title":"Expert Rev Clin Pharmacol"},{"key":"10.1124\/dmd.116.074450_bib31","series-title":"A Guide for IVIVE and PBPK\/PD Modeling Using the Simcyp Population-Based Simulator (Simcyp Manual Version 13)","year":"2013"},{"key":"10.1124\/dmd.116.074450_bib32","doi-asserted-by":"crossref","first-page":"478","DOI":"10.1038\/clpt.2014.46","article-title":"Physiologically based pharmacokinetic modeling: from regulatory science to regulatory policy","volume":"95","author":"Sinha","year":"2014","journal-title":"Clin Pharmacol Ther"},{"key":"10.1124\/dmd.116.074450_bib33","doi-asserted-by":"crossref","first-page":"1","DOI":"10.1016\/j.pharmthera.2005.05.010","article-title":"Effects of renal failure on drug transport and metabolism","volume":"109","author":"Sun","year":"2006","journal-title":"Pharmacol Ther"},{"key":"10.1124\/dmd.116.074450_bib34","doi-asserted-by":"crossref","first-page":"107","DOI":"10.1007\/s40259-013-0082-x","article-title":"Bosutinib: a review of its use in patients with Philadelphia chromosome-positive chronic myelogenous leukemia","volume":"28","author":"Syed","year":"2014","journal-title":"BioDrugs"},{"key":"10.1124\/dmd.116.074450_bib35","doi-asserted-by":"crossref","first-page":"1147","DOI":"10.1007\/s00228-008-0553-z","article-title":"Pharmacokinetics and dosage adjustment in patients with hepatic dysfunction","volume":"64","author":"Verbeeck","year":"2008","journal-title":"Eur J Clin Pharmacol"},{"key":"10.1124\/dmd.116.074450_bib36","doi-asserted-by":"crossref","first-page":"390","DOI":"10.1097\/00000542-198311000-00005","article-title":"The pharmacokinetics of midazolam in chronic renal failure patients","volume":"59","author":"Vinik","year":"1983","journal-title":"Anesthesiology"},{"key":"10.1124\/dmd.116.074450_bib37","doi-asserted-by":"crossref","first-page":"117","DOI":"10.1007\/s40262-014-0188-4","article-title":"Predicting the effect of cytochrome P450 inhibitors on substrate drugs: analysis of physiologically based pharmacokinetic modeling submissions to the US Food and Drug Administration","volume":"54","author":"Wagner","year":"2015","journal-title":"Clin Pharmacokinet"},{"key":"10.1124\/dmd.116.074450_bib38","doi-asserted-by":"crossref","first-page":"676","DOI":"10.2174\/138920007782109733","article-title":"Prediction of intestinal first-pass drug metabolism","volume":"8","author":"Yang","year":"2007","journal-title":"Curr Drug Metab"},{"issue":"Suppl","key":"10.1124\/dmd.116.074450_bib39","first-page":"79S","article-title":"Regulatory perspectives on designing pharmacokinetic studies and optimizing labeling recommendations for patients with chronic kidney disease","volume":"52","author":"Zhang","year":"2012","journal-title":"J Clin Pharmacol"},{"key":"10.1124\/dmd.116.074450_bib40","doi-asserted-by":"crossref","first-page":"305","DOI":"10.1038\/clpt.2008.208","article-title":"Assessment of the impact of renal impairment on systemic exposure of new molecular entities: evaluation of recent new drug applications","volume":"85","author":"Zhang","year":"2009","journal-title":"Clin Pharmacol Ther"},{"key":"10.1124\/dmd.116.074450_bib41","doi-asserted-by":"crossref","first-page":"351","DOI":"10.1177\/0091270008331196","article-title":"Quantitative evaluation of pharmacokinetic inhibition of CYP3A substrates by ketoconazole: a simulation study","volume":"49","author":"Zhao","year":"2009","journal-title":"J Clin Pharmacol"},{"key":"10.1124\/dmd.116.074450_bib42","doi-asserted-by":"crossref","first-page":"17","DOI":"10.1038\/clpt.2012.68","article-title":"Best practice in the use of physiologically based pharmacokinetic modeling and simulation to address clinical pharmacology regulatory questions","volume":"92","author":"Zhao","year":"2012","journal-title":"Clin Pharmacol Ther"},{"key":"10.1124\/dmd.116.074450_bib43","doi-asserted-by":"crossref","first-page":"259","DOI":"10.1038\/clpt.2010.298","article-title":"Applications of physiologically based pharmacokinetic (PBPK) modeling and simulation during regulatory review","volume":"89","author":"Zhao","year":"2011","journal-title":"Clin Pharmacol Ther"}],"container-title":["Drug Metabolism and Disposition"],"original-title":[],"language":"en","link":[{"URL":"https:\/\/api.elsevier.com\/content\/article\/PII:S0090955624053455?httpAccept=text\/xml","content-type":"text\/xml","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/api.elsevier.com\/content\/article\/PII:S0090955624053455?httpAccept=text\/plain","content-type":"text\/plain","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/syndication.highwire.org\/content\/doi\/10.1124\/dmd.116.074450","content-type":"unspecified","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2025,2,18]],"date-time":"2025-02-18T18:22:03Z","timestamp":1739902923000},"score":1,"resource":{"primary":{"URL":"https:\/\/linkinghub.elsevier.com\/retrieve\/pii\/S0090955624053455"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2017,4]]},"references-count":43,"journal-issue":{"issue":"4","published-print":{"date-parts":[[2017,4]]}},"alternative-id":["S0090955624053455"],"URL":"https:\/\/doi.org\/10.1124\/dmd.116.074450","relation":{},"ISSN":["0090-9556"],"issn-type":[{"value":"0090-9556","type":"print"}],"subject":[],"published":{"date-parts":[[2017,4]]},"assertion":[{"value":"Elsevier","name":"publisher","label":"This article is maintained by"},{"value":"Application of Physiologically Based Pharmacokinetic Modeling to the Understanding of Bosutinib Pharmacokinetics: Prediction of Drug\u2013Drug and Drug\u2013Disease Interactions","name":"articletitle","label":"Article Title"},{"value":"Drug Metabolism and Disposition","name":"journaltitle","label":"Journal Title"},{"value":"https:\/\/doi.org\/10.1124\/dmd.116.074450","name":"articlelink","label":"CrossRef DOI link to publisher maintained version"},{"value":"article","name":"content_type","label":"Content Type"},{"value":"\u00a9 2017 by The American Society for Pharmacology and Experimental Therapeutics","name":"copyright","label":"Copyright"}]}}