{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,4,29]],"date-time":"2026-04-29T22:01:06Z","timestamp":1777500066390,"version":"3.51.4"},"reference-count":55,"publisher":"Wiley","issue":"10","license":[{"start":{"date-parts":[[2025,10,17]],"date-time":"2025-10-17T00:00:00Z","timestamp":1760659200000},"content-version":"vor","delay-in-days":16,"URL":"http:\/\/creativecommons.org\/licenses\/by-nc-nd\/4.0\/"}],"content-domain":{"domain":["ascpt.onlinelibrary.wiley.com"],"crossmark-restriction":true},"short-container-title":["Clinical Translational Sci"],"published-print":{"date-parts":[[2025,10]]},"abstract":"<jats:title>ABSTRACT<\/jats:title>\n                  <jats:p>Rimegepant is a small molecule calcitonin gene\u2010related peptide receptor antagonist approved as a 75\u2009mg orally disintegrating tablet for the acute treatment of migraine and the prevention of episodic migraine in adults. A population pharmacokinetic model for oral rimegepant was previously developed using data from 11 phase I studies in adults. This analysis updated the population pharmacokinetic model with data from one pediatric (20 participants) and two adult (74 participants) studies. The resultant population pharmacokinetic model was used to predict rimegepant exposure following single or every\u2010other\u2010day dosing in a virtual pediatric population generated using United States national growth charts. Exposure with rimegepant 75\u2009mg orally disintegrating tablet was evaluated in simulated participants aged 6 to 17\u2009years (1000 simulations\/1\u2010year age group), and exposure with rimegepant 25, 35, 50, and 75\u2009mg was evaluated in simulated participants weighing 9 to 75\u2009kg (1000 simulations\/5\u2009kg increment). Rimegepant doses for pediatric patients were selected using predicted pediatric\/adult exposure ratios close to 1 and \u2264\u20092. The recommended single and every\u2010other\u2010day doses of rimegepant orally disintegrating tablet in the pediatric population were 75\u2009mg in adolescents 12 to &lt;\u200918\u2009years of age and children 6 to &lt;\u200912\u2009years of age and with a body weight &gt;\u200940\u2009kg; 50\u2009mg in children 6 to &lt;\u200912\u2009years of age with a body weight &gt;\u200925 to \u2264\u200940\u2009kg; and 35\u2009mg in children 6 to &lt;\u200912\u2009years of age with a body weight &gt;\u200915 to \u2264\u200925\u2009kg. These selected doses will support further evaluation of rimegepant efficacy and safety in pediatric patients with migraine.<\/jats:p>","DOI":"10.1111\/cts.70360","type":"journal-article","created":{"date-parts":[[2025,10,17]],"date-time":"2025-10-17T21:41:08Z","timestamp":1760737268000},"update-policy":"https:\/\/doi.org\/10.1002\/crossmark_policy","source":"Crossref","is-referenced-by-count":1,"title":["Exposure Matching Using Population Pharmacokinetic Modeling and Simulation to Support Rimegepant Dose Selection for Pediatric Patients With Migraine"],"prefix":"10.1111","volume":"18","author":[{"given":"Craig M.","family":"Comisar","sequence":"first","affiliation":[{"name":"Certara  Princeton New Jersey USA"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-1862-5805","authenticated-orcid":false,"given":"Jim H.","family":"Hughes","sequence":"additional","affiliation":[{"name":"Pfizer Inc.  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