Pediatric dosing for locally acting drugs in submissions to the U.S. Food and Drug Administration between 2002 and 2020

• Váldodahkkit: Gelareh A. Abulwerdi (Dahkki), Anuradha Ramamoorthy (Dahkki), Edward Bashaw (Dahkki), Gilbert J. Burckart (Dahkki), Rajanikanth Madabushi (Dahkki), Elimika Pfuma Fletcher (Dahkki)
• Materiálatiipa: Girji
• Almmustuhtton: Wiley, 2023-10-01T00:00:00Z.
• Fáttát: article
• Liŋkkat: Connect to this object online.

Abstract Deriving pediatric doses for locally acting drugs (LADs) presents a unique challenge because limited systemic exposure hinders commonly used approaches such as pharmacokinetic matching to adults. This study systematically evaluated drug development practices used for pediatric dose selectio...