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Clin Perinatol. 2012 Mar;39(1):11-23. doi: 10.1016/j.clp.2011.12.016. Epub 2012 Jan 21.

Drug studies in newborns: a therapeutic imperative.

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Obstetric and Pediatric Pharmacology Branch; Eunice Kennedy Shriver National Institute of Child Health and Human Development, 6100 Executive Boulevard,Rockville, MD 20852, USA.


Although some drugs have been developed for the neonate, drug development for the least mature and most vulnerable pediatric patients is lacking. Most of the drugs are off-label or off-patent and are empirically administered to newborns once efficacy has been demonstrated in adults and usefulness is suspected or demonstrated in the older pediatric population. Few drugs are approved by the Food and Drug Administration for use in this population. The factors that prevent the demonstration of efficacy and safety in the newborn are discussed and a change in the current approach for neonatal drug studies is suggested.

[Indexed for MEDLINE]

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