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Neonatal Safety Information Reported to the FDA During Drug Development Studies

BACKGROUND: Relatively few neonatal drug development studies have been conducted, but an increase is expected with the enactment of the Food and Drug Administration Safety and Innovation Act (FDASIA). Understanding the safety of drugs studied in neonates is complicated by the unique nature of the po...

Täydet tiedot

Tallennettuna:
Bibliografiset tiedot
Julkaisussa:Ther Innov Regul Sci
Päätekijät: Avant, Debbie, Baer, Gerri, Moore, Jason, Zheng, Panli, Sorbello, Alfred, Ariagno, Ron, Yao, Lynne, Burckart, Gilbert J., Wang, Jian
Aineistotyyppi: Artigo
Kieli:Inglês
Julkaistu: 2017
Aiheet:
Linkit:https://ncbi.nlm.nih.gov/pmc/articles/PMC5549935/
https://ncbi.nlm.nih.gov/pubmed/28804696
https://ncbi.nlm.nih.govhttp://dx.doi.org/10.1177/2168479017716713
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