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Stratification, Hypothesis Testing, and Clinical Trial Simulation in Pediatric Drug Development

BACKGROUND: Pediatric drug development is plagued by small sample sizes, unvalidated clinical endpoints, and limited studies. OBJECTIVES: The objective of this study was to determine whether age stratification within the pediatric population could be used to (1) assess response to a pharmacologic in...

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Detalhes bibliográficos
Publicado no:Ther Innov Regul Sci
Main Authors: McMahon, Ann W., Watt, Kevin, Wang, Jian, Green, Dionna, Tiwari, Ram, Burckart, Gilbert J.
Formato: Artigo
Idioma:Inglês
Publicado em: 2016
Assuntos:
Acesso em linha:https://ncbi.nlm.nih.gov/pmc/articles/PMC5069699/
https://ncbi.nlm.nih.gov/pubmed/27774353
https://ncbi.nlm.nih.govhttp://dx.doi.org/10.1177/2168479016651661
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