{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2025,10,23]],"date-time":"2025-10-23T01:39:31Z","timestamp":1761183571959,"version":"build-2065373602"},"reference-count":39,"publisher":"Elsevier BV","license":[{"start":{"date-parts":[[2024,4,1]],"date-time":"2024-04-01T00:00:00Z","timestamp":1711929600000},"content-version":"tdm","delay-in-days":0,"URL":"https:\/\/www.elsevier.com\/tdm\/userlicense\/1.0\/"},{"start":{"date-parts":[[2024,4,1]],"date-time":"2024-04-01T00:00:00Z","timestamp":1711929600000},"content-version":"tdm","delay-in-days":0,"URL":"https:\/\/www.elsevier.com\/legal\/tdmrep-license"}],"funder":[{"DOI":"10.13039\/501100002336","name":"Daiichi Sankyo Company","doi-asserted-by":"publisher","id":[{"id":"10.13039\/501100002336","id-type":"DOI","asserted-by":"publisher"}]},{"DOI":"10.13039\/501100002973","name":"Daiichi-Sankyo","doi-asserted-by":"publisher","award":["GPP 2022"],"award-info":[{"award-number":["GPP 2022"]}],"id":[{"id":"10.13039\/501100002973","id-type":"DOI","asserted-by":"publisher"}]}],"content-domain":{"domain":["elsevier.com","sciencedirect.com"],"crossmark-restriction":true},"short-container-title":["Drug Metabolism and Pharmacokinetics"],"published-print":{"date-parts":[[2024,4]]},"DOI":"10.1016\/j.dmpk.2024.101000","type":"journal-article","created":{"date-parts":[[2024,1,23]],"date-time":"2024-01-23T02:31:07Z","timestamp":1705977067000},"page":"101000","update-policy":"https:\/\/doi.org\/10.1016\/elsevier_cm_policy","source":"Crossref","is-referenced-by-count":1,"special_numbering":"C","title":["Physiologically based pharmacokinetic modeling to predict the clinical effect of azole antifungal agents as CYP3A inhibitors on azelnidipine pharmacokinetics"],"prefix":"10.1016","volume":"55","author":[{"given":"Akiko","family":"Watanabe","sequence":"first","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Masakatsu","family":"Kotsuma","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]}],"member":"78","reference":[{"key":"10.1016\/j.dmpk.2024.101000_bib1","doi-asserted-by":"crossref","first-page":"539","DOI":"10.1254\/fpj.122.539","article-title":"[Pharmacological profiles and clinical effects of azelnidipine, a long-acting calcium channel blocker]","volume":"122","author":"Sada","year":"2003","journal-title":"Nihon Yakurigaku Zasshi"},{"key":"10.1016\/j.dmpk.2024.101000_bib2","doi-asserted-by":"crossref","first-page":"57","DOI":"10.1016\/S0021-5198(19)40137-6","article-title":"Antihypertensive effects of CS-905, a novel dihydropyridine Ca++ channel blocker","volume":"51","author":"Oizumi","year":"1989","journal-title":"Jpn J Pharmacol"},{"key":"10.1016\/j.dmpk.2024.101000_bib3","unstructured":"Daiichi Sankyo Co., Ltd. Calblock\u00ae (azelnidipine) package Insert. https:\/\/www.data-index.co.jp\/dragdata\/pdf\/2\/430574_2149043F1020_2_14.pdf [In Japanese] 2021; ver. 2 [accessed 25 Feb 2023].."},{"key":"10.1016\/j.dmpk.2024.101000_bib4","doi-asserted-by":"crossref","first-page":"651","DOI":"10.2174\/1389200215666141125121511","article-title":"Drug interactions between nine antifungal agents and drugs metabolized by human cytochromes P450","volume":"15","author":"Niwa","year":"2014","journal-title":"Curr Drug Metabol"},{"key":"10.1016\/j.dmpk.2024.101000_bib5","doi-asserted-by":"crossref","first-page":"384","DOI":"10.1067\/mcp.2000.110216","article-title":"Duration of effect of grapefruit juice on the pharmacokinetics of the CYP3A4 substrate simvastatin","volume":"68","author":"Lilja","year":"2000","journal-title":"Clin Pharmacol Ther"},{"key":"10.1016\/j.dmpk.2024.101000_bib6","doi-asserted-by":"crossref","first-page":"410","DOI":"10.1016\/S0009-9236(97)90191-0","article-title":"Itraconazole greatly increases plasma concentrations and effects of felodipine","volume":"61","author":"Jalava","year":"1997","journal-title":"Clin Pharmacol Ther"},{"key":"10.1016\/j.dmpk.2024.101000_bib7","doi-asserted-by":"crossref","first-page":"143","DOI":"10.1016\/j.clpt.2005.04.005","article-title":"Adult AIDS Clinical Trials Group A5159 Protocol Team. Pharmacokinetic interactions between indinavir plus ritonavir and calcium channel blockers","volume":"78","author":"Glesby","year":"2005","journal-title":"Clin Pharmacol Ther"},{"key":"10.1016\/j.dmpk.2024.101000_bib8","doi-asserted-by":"crossref","first-page":"25","DOI":"10.1016\/S0009-9236(96)90163-0","article-title":"Erythromycin-felodipine interaction: magnitude, mechanism, and comparison with grapefruit juice","volume":"60","author":"Bailey","year":"1996","journal-title":"Clin Pharmacol Ther"},{"key":"10.1016\/j.dmpk.2024.101000_bib9","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":"10.1016\/j.dmpk.2024.101000_bib10","doi-asserted-by":"crossref","first-page":"21","DOI":"10.1016\/j.xphs.2018.10.033","article-title":"Physiologically based pharmacokinetic modeling in regulatory science: an update from the U.S. Food and Drug Administration's Office of Clinical Pharmacology","volume":"108","author":"Grimstein","year":"2019","journal-title":"J\u00a0Pharm Sci"},{"key":"10.1016\/j.dmpk.2024.101000_bib11","doi-asserted-by":"crossref","first-page":"88","DOI":"10.1002\/cpt.1013","article-title":"Physiologically based pharmacokinetic model qualification and reporting procedures for regulatory submissions: a consortium perspective","volume":"104","author":"Shebley","year":"2018","journal-title":"Clin Pharmacol Ther"},{"key":"10.1016\/j.dmpk.2024.101000_bib12","doi-asserted-by":"crossref","first-page":"413","DOI":"10.1002\/psp4.12203","article-title":"Quantitative modeling and simulation in PMDA: a Japanese regulatory perspective","volume":"6","author":"Sato","year":"2017","journal-title":"CPT Pharmacometrics Syst Pharmacol"},{"key":"10.1016\/j.dmpk.2024.101000_bib13","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":"10.1016\/j.dmpk.2024.101000_bib14","doi-asserted-by":"crossref","first-page":"98","DOI":"10.1002\/cpt.539","article-title":"Physiologically based pharmacokinetic modeling in regulatory decision-making at the European Medicines Agency","volume":"102","author":"Luzon","year":"2017","journal-title":"Clin Pharmacol Ther"},{"key":"10.1016\/j.dmpk.2024.101000_bib15","unstructured":"Sankyo Co., Ltd. Calblock\u00ae (azelnidipine) tablets 8 mg, 16 mg overview of application materials. https:\/\/www.pmda.go.jp\/drugs\/2003\/P200300002\/index.html [In Japanese] 2003 [accessed 25 Feb 2023].."},{"key":"10.1016\/j.dmpk.2024.101000_bib16","doi-asserted-by":"crossref","first-page":"127","DOI":"10.3999\/jscpt.37.3_127","article-title":"Effect of a single glass of grapefruit juice on the apparent oral bioavailability of the dihydropyridine calcium channel antagonist, azelnidipine in healthy Japanese volunteers","volume":"37","author":"Hirashima","year":"2006","journal-title":"Jpn J Clin Pharmacol Therapeut"},{"key":"10.1016\/j.dmpk.2024.101000_bib17","unstructured":"Stiefel Laboratories, Inc. Tradename (itraconazole) prescribing Information. 2010. https:\/\/www.accessdata.fda.gov\/drugsatfda_docs\/label\/2010\/022484s000lbl.pdf [accessed 25 Feb 2023].."},{"key":"10.1016\/j.dmpk.2024.101000_bib18","doi-asserted-by":"crossref","DOI":"10.1016\/j.dmpk.2021.100414","article-title":"Classification of drugs for evaluating drug interaction in drug development and clinical management","volume":"41","author":"Maeda","year":"2021","journal-title":"Drug Metabol Pharmacokinet"},{"key":"10.1016\/j.dmpk.2024.101000_bib19","doi-asserted-by":"crossref","first-page":"2613","DOI":"10.2165\/00003495-200363230-00004","article-title":"Azelnidipine","volume":"63","author":"Wellington","year":"2003","journal-title":"Drugs"},{"key":"10.1016\/j.dmpk.2024.101000_bib20","doi-asserted-by":"crossref","first-page":"170","DOI":"10.1124\/dmd.110.036103","article-title":"Critique of the two-fold measure of prediction success for ratios: application for the assessment of drug-drug interactions","volume":"39","author":"Guest","year":"2011","journal-title":"Drug Metab Dispos"},{"key":"10.1016\/j.dmpk.2024.101000_bib21","unstructured":"US Food and Drug Administration. Drug development and drug interactions: table of substrates, inhibitors and inducers. https:\/\/www.fda.gov\/drugs\/drug-interactions-labeling\/drug-development-and-drug-interactions-table-substrates-inhibitors-and-inducers. [accessed 25 Feb 2023].."},{"key":"10.1016\/j.dmpk.2024.101000_bib22","doi-asserted-by":"crossref","first-page":"2220","DOI":"10.1111\/cts.13082","article-title":"Model-based assessments of CYP3A-mediated drug-drug interaction risk of milademetan","volume":"14","author":"Hong","year":"2021","journal-title":"Clin Transl Sci"},{"key":"10.1016\/j.dmpk.2024.101000_bib23","doi-asserted-by":"crossref","DOI":"10.1016\/j.ejps.2019.105061","article-title":"Assessing pharmacokinetic differences in Caucasian and East Asian (Japanese, Chinese and Korean) populations driven by CYP2C19 polymorphism using physiologically-based pharmacokinetic modelling","volume":"139","author":"Zhou","year":"2019","journal-title":"Eur J Pharmaceut Sci"},{"key":"10.1016\/j.dmpk.2024.101000_bib24","doi-asserted-by":"crossref","first-page":"362","DOI":"10.1016\/j.clpt.2005.12.305","article-title":"Effect of voriconazole on the pharmacokinetics and pharmacodynamics of intravenous and oral midazolam","volume":"79","author":"Saari","year":"2006","journal-title":"Clin Pharmacol Ther"},{"key":"10.1016\/j.dmpk.2024.101000_bib25","doi-asserted-by":"crossref","first-page":"502","DOI":"10.1016\/j.clpt.2006.07.008","article-title":"Voriconazole, but not terbinafine, markedly reduces alfentanil clearance and prolongs its half-life","volume":"80","author":"Saari","year":"2006","journal-title":"Clin Pharmacol Ther"},{"key":"10.1016\/j.dmpk.2024.101000_bib26","unstructured":"Pharmaceutical and Medical Devices Agency. Prodif (fosfluconazole) application materials. https:\/\/www.pmda.go.jp\/drugs\/2003\/P200300028\/index.html [In Japanese] [accessed 25 Feb 2023].."},{"key":"10.1016\/j.dmpk.2024.101000_bib27","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 Metabol"},{"key":"10.1016\/j.dmpk.2024.101000_bib28","doi-asserted-by":"crossref","first-page":"805","DOI":"10.1002\/psp4.12791","article-title":"Guide to development of compound files for PBPK modeling in the Simcyp population-based simulator","volume":"11","author":"Ezuruike","year":"2022","journal-title":"CPT Pharmacometrics Syst Pharmacol"},{"year":"2013","key":"10.1016\/j.dmpk.2024.101000_bib29"},{"key":"10.1016\/j.dmpk.2024.101000_bib30","doi-asserted-by":"crossref","first-page":"245","DOI":"10.1124\/dmd.113.055400","article-title":"Amlodipine metabolism in human liver microsomes and roles of CYP3A4\/5 in the dihydropyridine dehydrogenation","volume":"42","author":"Zhu","year":"2014","journal-title":"Drug Metab Dispos"},{"key":"10.1016\/j.dmpk.2024.101000_bib31","doi-asserted-by":"crossref","first-page":"139","DOI":"10.1007\/s13318-018-0513-7","article-title":"Clinical pharmacokinetics of second-generation triazoles for the treatment of invasive Aspergillosis and Candidiasis","volume":"44","author":"Jovi\u0107","year":"2019","journal-title":"Eur J Drug Metab Pharmacokinet"},{"key":"10.1016\/j.dmpk.2024.101000_bib32","doi-asserted-by":"crossref","first-page":"649","DOI":"10.2165\/00003088-200645070-00002","article-title":"Pharmacokinetic\/pharmacodynamic profile of voriconazole","volume":"45","author":"Theuretzbacher","year":"2006","journal-title":"Clin Pharmacokinet"},{"year":"2015","key":"10.1016\/j.dmpk.2024.101000_bib33"},{"key":"10.1016\/j.dmpk.2024.101000_bib34","doi-asserted-by":"crossref","first-page":"477","DOI":"10.1111\/cts.12557","article-title":"Clinical drug-drug interaction potential of BFE1224, prodrug of antifungal ravuconazole, using two types of cocktails in healthy subjects","volume":"11","author":"Ishii","year":"2018","journal-title":"Clin Transl Sci"},{"key":"10.1016\/j.dmpk.2024.101000_bib35","doi-asserted-by":"crossref","first-page":"559","DOI":"10.1358\/mf.2005.27.8.928310","article-title":"Cytochrome P450 3A: genetic polymorphisms and inter-ethnic differences","volume":"27","author":"Krishna","year":"2005","journal-title":"Methods Find Exp Clin Pharmacol"},{"key":"10.1016\/j.dmpk.2024.101000_bib36","doi-asserted-by":"crossref","first-page":"224","DOI":"10.3389\/fgene.2019.00224","article-title":"Polymorphism in cytochrome P450 3A4 is ethnicity related","volume":"10","author":"Guttman","year":"2019","journal-title":"Front Genet"},{"key":"10.1016\/j.dmpk.2024.101000_bib37","doi-asserted-by":"crossref","first-page":"781","DOI":"10.1007\/s40262-019-00856-z","article-title":"A\u00a0physiologically based pharmacokinetic model of voriconazole integrating time-dependent inhibition of CYP3A4, genetic polymorphisms of CYP2C19 and predictions of drug-drug interactions","volume":"59","author":"Li","year":"2020","journal-title":"Clin Pharmacokinet"},{"key":"10.1016\/j.dmpk.2024.101000_bib38","doi-asserted-by":"crossref","first-page":"1805","DOI":"10.1248\/bpb.28.1805","article-title":"Effect of antifungal drugs on cytochrome P450 (CYP) 2C9, CYP2C19, and CYP3A4 activities in human liver microsomes","volume":"28","author":"Niwa","year":"2005","journal-title":"Biol Pharm Bull"},{"key":"10.1016\/j.dmpk.2024.101000_bib39","doi-asserted-by":"crossref","first-page":"2546","DOI":"10.1128\/AAC.46.8.2546-2553.2002","article-title":"Pharmacokinetics and safety of voriconazole following intravenous- to oral-dose escalation regimens","volume":"46","author":"Purkins","year":"2002","journal-title":"Antimicrob Agents Chemother"}],"container-title":["Drug Metabolism and Pharmacokinetics"],"original-title":[],"language":"en","link":[{"URL":"https:\/\/api.elsevier.com\/content\/article\/PII:S1347436724000065?httpAccept=text\/xml","content-type":"text\/xml","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/api.elsevier.com\/content\/article\/PII:S1347436724000065?httpAccept=text\/plain","content-type":"text\/plain","content-version":"vor","intended-application":"text-mining"}],"deposited":{"date-parts":[[2025,10,22]],"date-time":"2025-10-22T19:57:29Z","timestamp":1761163049000},"score":1,"resource":{"primary":{"URL":"https:\/\/linkinghub.elsevier.com\/retrieve\/pii\/S1347436724000065"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2024,4]]},"references-count":39,"alternative-id":["S1347436724000065"],"URL":"https:\/\/doi.org\/10.1016\/j.dmpk.2024.101000","relation":{},"ISSN":["1347-4367"],"issn-type":[{"type":"print","value":"1347-4367"}],"subject":[],"published":{"date-parts":[[2024,4]]},"assertion":[{"value":"Elsevier","name":"publisher","label":"This article is maintained by"},{"value":"Physiologically based pharmacokinetic modeling to predict the clinical effect of azole antifungal agents as CYP3A inhibitors on azelnidipine pharmacokinetics","name":"articletitle","label":"Article Title"},{"value":"Drug Metabolism and Pharmacokinetics","name":"journaltitle","label":"Journal Title"},{"value":"https:\/\/doi.org\/10.1016\/j.dmpk.2024.101000","name":"articlelink","label":"CrossRef DOI link to publisher maintained version"},{"value":"article","name":"content_type","label":"Content Type"},{"value":"\u00a9 2024 The Japanese Society for the Study of Xenobiotics. Published by Elsevier Ltd. All rights reserved.","name":"copyright","label":"Copyright"}],"article-number":"101000"}}