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

• Main Authors: Gelareh A. Abulwerdi (Author), Anuradha Ramamoorthy (Author), Edward Bashaw (Author), Gilbert J. Burckart (Author), Rajanikanth Madabushi (Author), Elimika Pfuma Fletcher (Author)
• Format: Book
• Published: Wiley, 2023-10-01T00:00:00Z.
• Subjects: article
• Online Access: 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...