Primary Endpoints in Pediatric Efficacy Trials Submitted to the US FDA

The selection of appropriate endpoints in pediatric drug development trials is a critical aspect of trial design. Given the high pediatric trial failure rate, selecting optimal trial design elements, such as the primary efficacy endpoint, is essential to ensuring increased potential for trial succes...

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Publicado en:J Clin Pharmacol
Autores principales: Green, Dionna J., Burnham, Janelle M., Schuette, Paul, Liu, Xiaomei I., Maas, Brian M., Yao, Lynne, McCune, Susan K., Chen, Joseph, van den Anker, John N., Burckart, Gilbert J.
Formato: Artigo
Lenguaje:Inglês
Publicado: 2018
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Article
Acceso en línea:https://ncbi.nlm.nih.gov/pmc/articles/PMC6112107/
https://ncbi.nlm.nih.gov/pubmed/29663424
https://ncbi.nlm.nih.govhttp://dx.doi.org/10.1002/jcph.1109
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