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A Composite Endpoint for Acceptability Evaluation of Oral Drug Formulations in the Pediatric Population

INTRODUCTION: A medicine’s acceptability is likely to have significant impact on pediatric adherence. The importance is underlined in EMA and FDA guidance on this topic where investigation of acceptability is stated as a regulatory expectation. Demonstrating acceptability can be challenging given th...

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Detalles Bibliográficos
Autores principales: Wargenau, Manfred, Reidemeister, Sibylle, Klingmann, Ingrid, Klingmann, Viviane
Formato: Online Artículo Texto
Lenguaje:English
Publicado: Springer International Publishing 2022
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9492601/
https://www.ncbi.nlm.nih.gov/pubmed/35471561
http://dx.doi.org/10.1007/s43441-022-00406-z