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Several published models describe the population PKs of dexmedetomidine in neonates, infants, children, and adolescents, though very few have been externally evaluated. A prospective PK dataset of dexmedetomidine plasma concentrations in children and young adults aged 0.01\u201019.9 years was collected as part of a multicenter opportunistic PK study. A PubMed search of studies reporting dexmedetomidine PK identified five population PK models developed with data from demographically similar children that were selected for external validation. A total of 168 plasma concentrations from 102 children were compared with both population (PRED) and individualized (IPRED) predicted values from each of the five published models by quantitative and visual analyses using NONMEM (v7.3) and R (v4.1.3). Mean percent prediction errors from observed values ranged from \u22121% to 120% for PRED, and \u221224% to 60% for IPRED. The model by James et al, which was developed using similar \u201creal\u2010world\u201d data, nearly met the generalizability criteria from IPRED predictions. Other models developed using clinical trial data may have been limited by inclusion\/exclusion criteria and a less racially diverse population than this study's opportunistic dataset. The James model may represent a useful, but limited tool for model\u2010informed dosing of hospitalized children.<\/jats:p>","DOI":"10.1002\/jcph.2434","type":"journal-article","created":{"date-parts":[[2024,3,28]],"date-time":"2024-03-28T08:44:37Z","timestamp":1711615477000},"page":"963-974","update-policy":"https:\/\/doi.org\/10.1002\/crossmark_policy","source":"Crossref","is-referenced-by-count":3,"title":["Using Real\u2010World Data to Externally Evaluate Population Pharmacokinetic Models of Dexmedetomidine in Children and Infants"],"prefix":"10.1002","volume":"64","author":[{"given":"Sean","family":"McCann","sequence":"first","affiliation":[{"name":"Division of Pharmacotherapy and Experimental Therapeutics UNC Eshelman School of Pharmacy, The University of North Carolina at Chapel Hill  Chapel Hill NC USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-6681-9356","authenticated-orcid":false,"given":"Vict\u00f3ria E.","family":"Helfer","sequence":"additional","affiliation":[{"name":"Division of Pharmacotherapy and Experimental Therapeutics UNC Eshelman School of Pharmacy, The University of North Carolina at Chapel Hill  Chapel Hill NC USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-4016-1680","authenticated-orcid":false,"given":"Stephen J.","family":"Balevic","sequence":"additional","affiliation":[{"name":"Department of Pediatrics Duke University Medical Center  Durham NC USA"},{"name":"Duke Clinical Research Institute  Durham NC USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Chi D.","family":"Hornik","sequence":"additional","affiliation":[{"name":"Department of Pediatrics Duke University Medical Center  Durham NC USA"},{"name":"Duke Clinical Research Institute  Durham NC USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Stuart L.","family":"Goldstein","sequence":"additional","affiliation":[{"name":"Cincinnati Children's Hospital Medical Center  Cincinnati OH USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Julie","family":"Autmizguine","sequence":"additional","affiliation":[{"name":"Department of Pediatrics Center Hospitalier Universitaire Sainte\u2010Justine  Montreal Quebec Canada"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Marisa","family":"Meyer","sequence":"additional","affiliation":[{"name":"Critical Care Medicine Nemours Children's Hospital, Delaware  Wilmington DE USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Amira","family":"Al\u2010Uzri","sequence":"additional","affiliation":[{"name":"Oregon Health and Science University  Portland OR USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Sarah G.","family":"Anderson","sequence":"additional","affiliation":[{"name":"The Emmes Company, LLC  Rockville MD USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Elizabeth H.","family":"Payne","sequence":"additional","affiliation":[{"name":"The Emmes Company, LLC  Rockville MD USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Sitora","family":"Turdalieva","sequence":"additional","affiliation":[{"name":"The Emmes Company, LLC  Rockville MD USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Daniel","family":"Gonzalez","sequence":"additional","affiliation":[{"name":"Duke Clinical Research Institute  Durham NC USA"},{"name":"Division of Clinical Pharmacology Department of Medicine Duke University School of Medicine  Durham NC USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"name":"the Best Pharmaceuticals for Children Act \u2013 Pediatric Trials Network Steering Committee","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"311","published-online":{"date-parts":[[2024,3,28]]},"reference":[{"key":"e_1_2_12_2_1","doi-asserted-by":"publisher","DOI":"10.2165\/11207190-000000000-00000"},{"key":"e_1_2_12_3_1","unstructured":"Precedex [package insert]. 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