{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,11,3]],"date-time":"2026-11-03T18:32:40Z","timestamp":1793730760524,"version":"4.6.1"},"reference-count":28,"publisher":"Wiley","issue":"3","license":[{"start":{"date-parts":[[2018,12,18]],"date-time":"2018-12-18T00:00:00Z","timestamp":1545091200000},"content-version":"vor","delay-in-days":0,"URL":"http:\/\/creativecommons.org\/licenses\/by-nc-nd\/4.0\/"}],"funder":[{"DOI":"10.13039\/100004337","name":"Roche","doi-asserted-by":"publisher","id":[{"id":"10.13039\/100004337","id-type":"DOI","asserted-by":"publisher"}]}],"content-domain":{"domain":["ascpt.onlinelibrary.wiley.com"],"crossmark-restriction":true},"short-container-title":["CPT Pharmacom &amp; Syst Pharma"],"published-print":{"date-parts":[[2019,3]]},"abstract":"<jats:p>Intravenous ganciclovir and oral valganciclovir are effective in the prevention and treatment of pediatric cytomegalovirus (<jats:styled-content style=\"fixed-case\">CMV<\/jats:styled-content>) infection but various dosing regimens are used in medical practice. Population pharmacokinetic (PopPK) model\u2010based simulations were used to propose a new ganciclovir pediatric dosing algorithm for regulatory review and to evaluate the approved valganciclovir pediatric dosing algorithm against published dosing recommendations derived from quantitative approaches. Oral valganciclovir (mg\u00a0=\u00a07\u00a0\u00d7\u00a0body surface area (<jats:styled-content style=\"fixed-case\">BSA<\/jats:styled-content>)\u00a0\u00d7\u00a0creatinine clearance according to the Schwarz formula (Cr<jats:styled-content style=\"fixed-case\">CLS<\/jats:styled-content>) daily) and i.v. ganciclovir (mg\u00a0=\u00a03\u00a0\u00d7\u00a0<jats:styled-content style=\"fixed-case\">BSA<\/jats:styled-content>\u00a0\u00d7\u00a0Cr<jats:styled-content style=\"fixed-case\">CLS<\/jats:styled-content> daily) are effective in reaching ganciclovir target exposure for the prevention of <jats:styled-content style=\"fixed-case\">CMV<\/jats:styled-content> (area under the concentration\u2010time curve (<jats:styled-content style=\"fixed-case\">AUC<\/jats:styled-content>)<jats:sub>0\u201324<\/jats:sub> 40\u201360\u00a0\u03bcg\u00a0\u2219\u00a0hour\/<jats:styled-content style=\"fixed-case\">mL<\/jats:styled-content>) in most pediatric patients across the full pediatric age range. In contrast, ganciclovir and valganciclovir dosing based on body weight, as commonly used in medical practice, leads to underexposure, particularly in younger pediatric patients. This example shows that model\u2010based dosing algorithms built on clinical pharmacology and implemented using good modeling practice can prevent underexposure and reduce the risk of treatment failure in pediatric patients.<\/jats:p>","DOI":"10.1002\/psp4.12363","type":"journal-article","created":{"date-parts":[[2018,10,24]],"date-time":"2018-10-24T19:39:05Z","timestamp":1540409945000},"page":"167-176","update-policy":"https:\/\/doi.org\/10.1002\/crossmark_policy","source":"Crossref","is-referenced-by-count":37,"title":["Pediatric Dosing of Ganciclovir and Valganciclovir: How Model\u2010Based Simulations Can Prevent Underexposure and Potential Treatment Failure"],"prefix":"10.1002","volume":"8","author":[{"given":"Karin","family":"Jorga","sequence":"first","affiliation":[{"name":"KarinJorga Life Science Consulting GmbH  Basel Switzerland"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Bruno","family":"Reigner","sequence":"additional","affiliation":[{"name":"Pharma Research &amp; Development Pharmaceutical Sciences\u2010Clinical Pharmacology Roche Innovation Center Basel F. 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