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Using real\u2010world therapeutic drug monitoring data, we performed a pharmacometric analysis for 315 pediatric patients (&gt;1 month to &lt;18 years of age) who received lacosamide as both monotherapy and adjunctive therapy. Population pharmacokinetic modeling was performed using nonlinear mixed\u2010effects modeling with a 1\u2010compartment structural model with linear elimination, where clearance and volume of distribution were allometrically scaled for body weight, with no further need for age\u2010associated maturation functions. A covariate analysis for age, sex, race, and coadministration of other antiepileptic drugs identified phenobarbital and felbamate to significantly increase lacosamide clearance (1.71\u2010 and 1.46\u2010fold, respectively). Based on the developed population pharmacokinetic model, simulations were performed in virtual pediatric patients to explore age\u2010associated dose requirements to match lacosamide exposure in patient groups of different age with the exposure achieved in children \u22654 year of age with the weight\u2010based dosing recommendations provided by the US Food and Drug Administration. Based on this approach, our analysis suggested that children \u22653 years of age needed the same dose as recommended by the US Food and Drug Administration for children \u22654 years of age (12 mg\/kg\/d), while children 1 to 3 years of age may need 13 to 14 mg\/kg\/d and infants between 1 month and 1 year of age may need 15 to 18 mg\/kg\/d (based on their actual age) to match the exposure seen in children \u22654 years of age.<\/jats:p>","DOI":"10.1002\/jcph.1840","type":"journal-article","created":{"date-parts":[[2021,2,18]],"date-time":"2021-02-18T06:23:16Z","timestamp":1613629396000},"page":"881-888","update-policy":"https:\/\/doi.org\/10.1002\/crossmark_policy","source":"Crossref","is-referenced-by-count":22,"title":["Use of Real\u2010World Data and Pharmacometric Modeling in Support of Lacosamide Dosing in Pediatric Patients Under 4 Years of Age"],"prefix":"10.1002","volume":"61","author":[{"ORCID":"https:\/\/orcid.org\/0000-0001-8034-7810","authenticated-orcid":false,"given":"Pradeep B.","family":"Lukka","sequence":"first","affiliation":[{"name":"Department of Pharmaceutical Sciences College of Pharmacy The University of Tennessee Health Science Center  Memphis Tennessee USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Megan","family":"Woods","sequence":"additional","affiliation":[{"name":"Department of Pharmacy Le Bonheur Children's Hospital  Memphis Tennessee USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Rebecca","family":"Chhim","sequence":"additional","affiliation":[{"name":"Department of Pharmacy Le Bonheur Children's Hospital  Memphis Tennessee USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Stephanie J.","family":"Phelps","sequence":"additional","affiliation":[{"name":"Department of Clinical Pharmacy and Translational Science College of Pharmacy The University of Tennessee Health Science Center  Memphis Tennessee USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"James W.","family":"Wheless","sequence":"additional","affiliation":[{"name":"Division of Pediatric Neurology College of Medicine The University of Tennessee Health Science Center  Memphis Tennessee USA"},{"name":"Neuroscience Institute Le Bonheur Children's Hospital  Memphis Tennessee USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-3923-3648","authenticated-orcid":false,"given":"Bernd","family":"Meibohm","sequence":"additional","affiliation":[{"name":"Department of Pharmaceutical Sciences College of Pharmacy The University of Tennessee Health Science Center  Memphis Tennessee USA"}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"311","published-online":{"date-parts":[[2021,3,11]]},"reference":[{"key":"e_1_2_8_2_1","volume-title":"Vimpat\u00ae (Lacosamide) US Prescribing Information","author":"UCB Pharma"},{"key":"e_1_2_8_3_1","volume-title":"Vimpat\u00ae (Lacosamide) Summary of Product Characteristics","author":"EMA"},{"key":"e_1_2_8_4_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.nurt.2006.10.004"},{"key":"e_1_2_8_5_1","doi-asserted-by":"publisher","DOI":"10.1542\/peds.2010-3487"},{"key":"e_1_2_8_6_1","doi-asserted-by":"publisher","DOI":"10.1111\/epi.13859"},{"key":"e_1_2_8_7_1","doi-asserted-by":"publisher","DOI":"10.1007\/s40272-018-0286-0"},{"key":"e_1_2_8_8_1","volume-title":"Drugs for Treatment of Partial Onset Seizures: Full Extrapolation of Efficacy From Adults to Pediatric Patients 2 Years of Age and Older. 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