{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,3,5]],"date-time":"2026-03-05T15:33:17Z","timestamp":1772724797234,"version":"3.50.1"},"reference-count":19,"publisher":"Elsevier BV","issue":"3","license":[{"start":{"date-parts":[[2026,3,1]],"date-time":"2026-03-01T00:00:00Z","timestamp":1772323200000},"content-version":"tdm","delay-in-days":0,"URL":"https:\/\/www.elsevier.com\/tdm\/userlicense\/1.0\/"},{"start":{"date-parts":[[2026,3,1]],"date-time":"2026-03-01T00:00:00Z","timestamp":1772323200000},"content-version":"tdm","delay-in-days":0,"URL":"https:\/\/www.elsevier.com\/legal\/tdmrep-license"},{"start":{"date-parts":[[2026,2,2]],"date-time":"2026-02-02T00:00:00Z","timestamp":1769990400000},"content-version":"vor","delay-in-days":0,"URL":"http:\/\/creativecommons.org\/licenses\/by-nc-nd\/4.0\/"}],"funder":[{"DOI":"10.13039\/100006483","name":"AbbVie","doi-asserted-by":"publisher","id":[{"id":"10.13039\/100006483","id-type":"DOI","asserted-by":"publisher"}]}],"content-domain":{"domain":["jpharmsci.org","elsevier.com","sciencedirect.com"],"crossmark-restriction":true},"short-container-title":["Journal of Pharmaceutical Sciences"],"published-print":{"date-parts":[[2026,3]]},"DOI":"10.1016\/j.xphs.2026.104185","type":"journal-article","created":{"date-parts":[[2026,1,30]],"date-time":"2026-01-30T17:03:30Z","timestamp":1769792610000},"page":"104185","update-policy":"https:\/\/doi.org\/10.1016\/elsevier_cm_policy","source":"Crossref","is-referenced-by-count":0,"title":["Development of a mechanistic in vitro-in vivo correlation for upadacitinib using physiologically-based pharmacokinetic modeling"],"prefix":"10.1016","volume":"115","author":[{"given":"Md Mahbubul Huq","family":"Riad","sequence":"first","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Sumit","family":"Bhatnagar","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Susan","family":"George","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-9954-3798","authenticated-orcid":false,"given":"Patrick","family":"Marroum","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]}],"member":"78","reference":[{"key":"10.1016\/j.xphs.2026.104185_bib0001","doi-asserted-by":"crossref","DOI":"10.1111\/cts.13688","article-title":"Upadacitinib: mechanism of action, clinical, and translational science","volume":"17","author":"Mohamed","year":"2024","journal-title":"Clin Transl Sci"},{"key":"10.1016\/j.xphs.2026.104185_bib0002","series-title":"RINVOQ (upadacitinib) [package insert]","year":"2025"},{"key":"10.1016\/j.xphs.2026.104185_bib0003","unstructured":"US Food and Drug Administration. Waiver of in vivo bioavailability and bioequivalence studies for immediate-release solid oral dosage forms based on a biopharmaceutics classification system. 2017. Available at https:\/\/collections.nlm.nih.gov\/catalog\/nlm:nlmuid-101720038-pdf. Accessed February 1, 2025."},{"key":"10.1016\/j.xphs.2026.104185_bib0004","unstructured":"European Medicines Agency. Guideline on the pharmacokinetic and clinical evaluation of modified release dosage forms. 2014. Available at https:\/\/www.ema.europa.eu\/en\/pharmacokinetic-clinical-evaluation-modified-release-dosage-forms-scientific-guideline. Accessed February 1, 2025."},{"key":"10.1016\/j.xphs.2026.104185_bib0005","unstructured":"US Food and Drug Administration. Guidance for industry: extended release oral dosage forms: development, evaluation, and application of in vitro\/in vivo correlations. 1997. Available at https:\/\/www.fda.gov\/regulatory-information\/search-fda-guidance-documents\/extended-release-oral-dosage-forms-development-evaluation-and-application-vitroin-in-vivo-correlations. Accessed February 1, 2025."},{"key":"10.1016\/j.xphs.2026.104185_bib0006","doi-asserted-by":"crossref","first-page":"108","DOI":"10.1208\/s12248-019-0378-y","article-title":"Development of in vitro\u2013in vivo correlation for upadacitinib extended-release tablet formulation","volume":"21","author":"Mohamed","year":"2019","journal-title":"AAPS J"},{"key":"10.1016\/j.xphs.2026.104185_bib0007","doi-asserted-by":"crossref","first-page":"1335","DOI":"10.1002\/cpdd.957","article-title":"Effect of upadacitinib on the pharmacokinetics of rosuvastatin or atorvastatin in healthy subjects","volume":"10","author":"Mohamed","year":"2021","journal-title":"Clin Pharmacol Drug Dev"},{"key":"10.1016\/j.xphs.2026.104185_bib0008","doi-asserted-by":"crossref","first-page":"1547","DOI":"10.1007\/s40262-016-0419-y","article-title":"Pharmacokinetics, safety and tolerability of ABT-494, a novel selective JAK 1 inhibitor, in healthy volunteers and subjects with rheumatoid arthritis","volume":"55","author":"Mohamed","year":"2016","journal-title":"Clin Pharmacokinet"},{"key":"10.1016\/j.xphs.2026.104185_bib0009","doi-asserted-by":"crossref","first-page":"2242","DOI":"10.1111\/bcp.13329","article-title":"Assessment of effect of CYP3A inhibition, CYP induction, OATP1B inhibition, and high-fat meal on pharmacokinetics of the JAK1 inhibitor upadacitinib","volume":"83","author":"Mohamed","year":"2017","journal-title":"Br J Clin Pharmacol"},{"key":"10.1016\/j.xphs.2026.104185_bib0010","doi-asserted-by":"crossref","first-page":"86","DOI":"10.1002\/jcph.1496","article-title":"Effects of upadacitinib coadministration on the pharmacokinetics of sensitive cytochrome P450 probe substrates: a study with the modified Cooperstown 5+1 cocktail","volume":"60","author":"Mohamed","year":"2020","journal-title":"J Clin Pharmacol"},{"key":"10.1016\/j.xphs.2026.104185_bib0011","article-title":"Pharmacokinetics of ABT-494 with the once-daily extended-release tablet formulation being utilized in the ongoing rheumatoid arthritis phase 3 trials [abstract]","volume":"68","author":"Mohamed","year":"2016","journal-title":"Arthritis Rheumatol"},{"key":"10.1016\/j.xphs.2026.104185_bib0012","doi-asserted-by":"crossref","first-page":"1966","DOI":"10.1056\/NEJMoa2212728","article-title":"Upadacitinib induction and maintenance therapy for Crohn\u2019s disease","volume":"388","author":"Loftus","year":"2023","journal-title":"N Engl J Med"},{"key":"10.1016\/j.xphs.2026.104185_bib0013","doi-asserted-by":"crossref","first-page":"208","DOI":"10.1002\/cpdd.462","article-title":"Pharmacokinetics of upadacitinib with the clinical regimens of the extended-release formulation utilized in rheumatoid arthritis phase 3 trials","volume":"8","author":"Mohamed","year":"2019","journal-title":"Clin Pharmacol Drug Dev"},{"key":"10.1016\/j.xphs.2026.104185_bib0014","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.xphs.2026.104185_bib0015","doi-asserted-by":"crossref","first-page":"2065","DOI":"10.1021\/acs.molpharmaceut.4c00202","article-title":"Physiologically based biopharmaceutics modeling (PBBM): best practices for drug product quality, regulatory and industry perspectives: 2023 workshop summary report","volume":"21","author":"Mackie","year":"2024","journal-title":"Mol Pharm"},{"key":"10.1016\/j.xphs.2026.104185_bib0016","doi-asserted-by":"crossref","first-page":"491","DOI":"10.1208\/s12248-012-9359-0","article-title":"In vitro\u2013in vivo correlations: tricks and traps","volume":"14","author":"Cardot","year":"2012","journal-title":"AAPS J"},{"key":"10.1016\/j.xphs.2026.104185_bib0017","doi-asserted-by":"crossref","first-page":"528","DOI":"10.1002\/jcph.1550","article-title":"Pharmacokinetics of upadacitinib in healthy subjects and subjects With rheumatoid arthritis, Crohn\u2019s disease, ulcerative colitis, or atopic dermatitis: population analyses of phase 1 and 2 clinical trials","volume":"60","author":"Nader","year":"2020","journal-title":"J Clin Pharmacol"},{"key":"10.1016\/j.xphs.2026.104185_bib0018","doi-asserted-by":"crossref","first-page":"1379","DOI":"10.1208\/s12248-016-9966-2","article-title":"Regulatory experience with in vivo in vitro correlations (IVIVC) in new drug applications","volume":"18","author":"Suarez-Sharp","year":"2016","journal-title":"AAPS J"},{"key":"10.1016\/j.xphs.2026.104185_bib0019","doi-asserted-by":"crossref","first-page":"635","DOI":"10.3390\/polym14030635","article-title":"HPMC hydrogel formation mechanisms unveiled by the evaluation of the activation energy","volume":"14","author":"Perez-Robles","year":"2022","journal-title":"Polymers"}],"container-title":["Journal of Pharmaceutical Sciences"],"original-title":[],"language":"en","link":[{"URL":"https:\/\/api.elsevier.com\/content\/article\/PII:S0022354926000341?httpAccept=text\/xml","content-type":"text\/xml","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/api.elsevier.com\/content\/article\/PII:S0022354926000341?httpAccept=text\/plain","content-type":"text\/plain","content-version":"vor","intended-application":"text-mining"}],"deposited":{"date-parts":[[2026,3,5]],"date-time":"2026-03-05T14:32:29Z","timestamp":1772721149000},"score":1,"resource":{"primary":{"URL":"https:\/\/linkinghub.elsevier.com\/retrieve\/pii\/S0022354926000341"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2026,3]]},"references-count":19,"journal-issue":{"issue":"3","published-print":{"date-parts":[[2026,3]]}},"alternative-id":["S0022354926000341"],"URL":"https:\/\/doi.org\/10.1016\/j.xphs.2026.104185","relation":{},"ISSN":["0022-3549"],"issn-type":[{"value":"0022-3549","type":"print"}],"subject":[],"published":{"date-parts":[[2026,3]]},"assertion":[{"value":"Elsevier","name":"publisher","label":"This article is maintained by"},{"value":"Development of a mechanistic in vitro-in vivo correlation for upadacitinib using physiologically-based pharmacokinetic modeling","name":"articletitle","label":"Article Title"},{"value":"Journal of Pharmaceutical Sciences","name":"journaltitle","label":"Journal Title"},{"value":"https:\/\/doi.org\/10.1016\/j.xphs.2026.104185","name":"articlelink","label":"CrossRef DOI link to publisher maintained version"},{"value":"article","name":"content_type","label":"Content Type"},{"value":"\u00a9 2026 AbbVie Inc. Published by Elsevier Inc. on behalf of American Pharmacists Association.","name":"copyright","label":"Copyright"}],"article-number":"104185"}}