{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,10,15]],"date-time":"2026-10-15T12:51:31Z","timestamp":1792068691402,"version":"4.4.0"},"reference-count":28,"publisher":"Wiley","issue":"10","license":[{"start":{"date-parts":[[2026,9,21]],"date-time":"2026-09-21T00:00:00Z","timestamp":1789948800000},"content-version":"vor","delay-in-days":0,"URL":"http:\/\/creativecommons.org\/licenses\/by-nc-nd\/4.0\/"},{"start":{"date-parts":[[2026,9,21]],"date-time":"2026-09-21T00:00:00Z","timestamp":1789948800000},"content-version":"tdm","delay-in-days":0,"URL":"http:\/\/doi.wiley.com\/10.1002\/tdm_license_1.1"}],"content-domain":{"domain":["ascpt.onlinelibrary.wiley.com"],"crossmark-restriction":true},"short-container-title":["CPT Pharmacom &amp;amp; Syst Pharma"],"published-print":{"date-parts":[[2026,10]]},"abstract":"<jats:title>ABSTRACT<\/jats:title>\n                  <jats:p>Although timolol ophthalmic solutions or hospital\u2010compounded formulations have been used off\u2010label for the treatment of superficial infantile hemangioma (IH), no topical timolol formulation has been developed specifically for this indication. This study was the first to develop a population pharmacokinetic (popPK) model for topical timolol maleate gel and to perform exploratory exposure\u2013safety analyses. Data from Phase I\u2013III clinical trials in healthy adults and infants with proliferative superficial IH were used to develop the popPK model. Potential covariate effects on the pharmacokinetics were investigated, and exploratory relationships between timolol exposure and safety outcomes were assessed. A total of 810 plasma concentration measurements from 138 subjects (24 healthy adults and 114 infants) were included in the popPK analysis. Timolol pharmacokinetics were well described by a one\u2010compartment model with first\u2010order absorption and elimination. No significant covariates influencing clearance were identified. No apparent associations were identified between timolol exposure and the evaluated safety outcomes. Overall, systemic exposure following administration of this topical timolol maleate gel formulation was limited, supporting its favorable safety profile in infants with superficial IH. These quantitative findings may help guide its rational clinical use.<\/jats:p>","DOI":"10.1002\/psp4.70334","type":"journal-article","created":{"date-parts":[[2026,9,21]],"date-time":"2026-09-21T07:45:01Z","timestamp":1789976701000},"update-policy":"https:\/\/doi.org\/10.1002\/crossmark_policy","source":"Crossref","is-referenced-by-count":0,"title":["Population Pharmacokinetics of Topical Timolol Maleate Gel in Healthy Volunteers and Infants With Superficial Infantile Hemangioma"],"prefix":"10.1002","volume":"15","author":[{"given":"Li","family":"Li","sequence":"first","affiliation":[{"name":"Department of Dermatology Beijing Children's Hospital, Capital Medical University, Key Laboratory of Major Diseases in Children, Ministry of Education, National Center for Children's Health  Beijing China"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Yanming","family":"Li","sequence":"additional","affiliation":[{"name":"Department of Pharmacy, Beijing Children's Hospital Capital Medical University, National Center for Children's Health  Beijing China"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Fan","family":"Hu","sequence":"additional","affiliation":[{"name":"Department of Pediatrics West China Second University Hospital, Sichuan University  Chengdu China"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Deming","family":"Wang","sequence":"additional","affiliation":[{"name":"Vascular Anomaly Center, Department of Interventional Therapy Shanghai Ninth People's Hospital, Shanghai Jiao Tong University School of Medicine  Shanghai China"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Ning","family":"Sun","sequence":"additional","affiliation":[{"name":"Department of Pharmacy, Beijing Children's Hospital Capital Medical University, National Center for Children's Health  Beijing 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