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...

Ausführliche Beschreibung

Gespeichert in:
Bibliographische Detailangaben
Veröffentlicht in:J Clin Pharmacol
Hauptverfasser: 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.
Format: Artigo
Sprache:Inglês
Veröffentlicht: 2018
Schlagworte:
Article
Online Zugang: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
Tags: Tag hinzufügen
Keine Tags, Fügen Sie den ersten Tag hinzu!

Ähnliche Einträge