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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 no: | Clin Pharmacol Ther |
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| Main Authors: | , , , , , , , , |
| Formato: | Artigo |
| Idioma: | Inglês |
| Publicado em: |
2018
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| Assuntos: | |
| Acesso em linha: | 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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