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

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 selection of LADs...

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Detalles Bibliográficos
Autores principales: Abulwerdi, Gelareh A., Ramamoorthy, Anuradha, Bashaw, Edward, Burckart, Gilbert J., Madabushi, Rajanikanth, Fletcher, Elimika Pfuma
Formato: Online Artículo Texto
Lenguaje:English
Publicado: John Wiley and Sons Inc. 2023
Materias:
Research
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10582654/
https://www.ncbi.nlm.nih.gov/pubmed/37551830
http://dx.doi.org/10.1111/cts.13611

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