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