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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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Dettagli Bibliografici
Pubblicato in:J Clin Pharmacol
Autori principali: 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.
Natura: Artigo
Lingua:Inglês
Pubblicazione: 2018
Soggetti:
Accesso online: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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