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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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Shranjeno v:
Bibliografske podrobnosti
izdano v:J Clin Pharmacol
Main Authors: 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
Jezik:Inglês
Izdano: 2018
Teme:
Online dostop: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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