Clinical Research in Newborn Infants: Difficulties and Specificity
European journal of clinical pharmacology 2011 May; 67 Suppl 1: 29-32
Clinical trials are essential in neonates to evaluate scientifically the efficacy and safety of drugs. However, major specificities condition clinical research in human neonates.
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Skupski, Daniel W; Chervenak, Frank A; McCullough, Laurence B; Bancalari, Eduardo; Haumont, Dominique; Simeoni, Umberto; Saugstad, Ola; Donn, Steven; Arabin, Birgit; Greenough, Anne; Donzelli, Gianpaolo; Levene, Malcolm; Sen, Cihat; Carbonell, Xavier; Dudenhausen, Joachim W; Vladareanu, Radu; Antsaklis, Aris; Papp, Zoltan; Aksit, Mehmet; Carrapato, Manuel (2010-11)The birth of neonates at the limits of viability, or periviability, poses numerous challenges to health care providers and to systems of care, and the care of these pregnancies and neonates is fraught with ethical ...