Surrogate Endpoints in Pediatric Studies Submitted to the US FDA

The 21(st) Century Cures Act was passed in December, 2016, and included a number of provisions to facilitate drug approval. Considerable discussion was generated related to some aspects of the Act, especially to the use of surrogate endpoints (SEs) as a means to shorten the time required prior to re...

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Publicado en:Clin Pharmacol Ther
Main Authors: Green, Dionna J., Sun, Haihao, Burnham, Janelle, Liu, Xiaomei I., van den Anker, John, Temeck, Jean, Yao, Lynne, McCune, Susan K., Burckart, Gilbert J.
Formato: Artigo
Idioma:Inglês
Publicado: 2018
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Article
Acceso en liña:https://ncbi.nlm.nih.gov/pmc/articles/PMC6481930/
https://ncbi.nlm.nih.gov/pubmed/30094815
https://ncbi.nlm.nih.govhttp://dx.doi.org/10.1002/cpt.1117
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