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

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

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...

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Bibliographic Details
Main Authors: Gelareh A. Abulwerdi, Anuradha Ramamoorthy, Edward Bashaw, Gilbert J. Burckart, Rajanikanth Madabushi, Elimika Pfuma Fletcher
Format: Article
Language:English
Published: Wiley 2023-10-01
Series:Clinical and Translational Science
Online Access:https://doi.org/10.1111/cts.13611

Internet

https://doi.org/10.1111/cts.13611

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