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To determine the selection of an appropriate dose regimen in children for induction and maintenance, a population pharmacokinetic approach was used (nonlinear mixed\u2010effect modeling), combining pediatric data with data from adults with GPA\/MPA. The time course of B\u2010cell depletion was assessed in both populations. The exposure\u2010effect relationship was assessed by logistic regression. Twenty\u2010five pediatric patients (80% female patients; age range, 6\u201317\u2009years) were enrolled in the trial and received the induction regimen of intravenous rituximab 375\u2009mg\/m<jats:sup>2<\/jats:sup> weekly for 4\u2009weeks, which resulted in a similar exposure to that of adults. Based on pharmacokinetic modeling, a maintenance dosing regimen of 250\u2009mg\/m<jats:sup>2<\/jats:sup> administered twice over 14\u2009days followed by 250\u2009mg\/m<jats:sup>2<\/jats:sup> every 6\u2009months is expected to result in similar rituximab exposure as that of adults receiving the approved maintenance dose of 500\u2009mg administered twice over 14\u2009days followed by 500\u2009mg every 6\u2009months. The time course of B\u2010cell depletion was similar between the pediatric and adult populations, supporting the similarities in response in both populations and allowing extrapolation to patients less than 6\u2009years old. Using a partial extrapolation approach helped identify safe and effective dosing regimens of rituximab in pediatric patients with GPA\/MPA and lead to regulatory approval.<\/jats:p>","DOI":"10.1111\/cts.13351","type":"journal-article","created":{"date-parts":[[2022,6,29]],"date-time":"2022-06-29T04:49:19Z","timestamp":1656478159000},"page":"2172-2183","update-policy":"https:\/\/doi.org\/10.1002\/crossmark_policy","source":"Crossref","is-referenced-by-count":8,"title":["Rituximab pediatric drug development: Pharmacokinetic and pharmacodynamic modeling to inform regulatory approval for rituximab treatment in patients with granulomatosis with polyangiitis or microscopic polyangiitis"],"prefix":"10.1111","volume":"15","author":[{"given":"Candice","family":"Jamois","sequence":"first","affiliation":[{"name":"Clinical Pharmacology, Pharmaceutical Sciences, Pharma Research and Early Development Roche Innovation Center Basel  Basel Switzerland"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Leonid","family":"Gibiansky","sequence":"additional","affiliation":[{"name":"QuantPharm LLC  North Potomac Maryland USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Clarisse","family":"Chavanne","sequence":"additional","affiliation":[{"name":"Clinical Pharmacology, Pharmaceutical Sciences, Pharma Research and Early Development Roche Innovation Center Basel  Basel Switzerland"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Melissa","family":"Cheu","sequence":"additional","affiliation":[{"name":"BioAnalytical Sciences Genentech Inc.  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