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INTRODUCTION The key feature of the newborn is its fast age-dependent maturation, resulting in extensive variability in pharmacokinetics and -dynamics, further aggravated by newly emerging covariates like treatment modalities, environmental issues or pharmacogenetics. This makes clinical research in neonates relevant and needed, but also challenging. (More)
A defined by the US Food and Drug Administration (FDA), regulatory science is the “science of developing new tools, standards and approaches to assess the safety, efficacy, quality and performance of all FDA-regulated products” (1). Nowhere is the need greatest for such standardized methods and new approaches than for the regulation of medicines for(More)
Because the highest rates of morbidity and mortality in neonates are seen in those born at <32 weeks' gestation, this group has the most urgent need for novel therapies to improve survival and outcome. Legislative efforts in the United States and Europe have attempted to address this issue by requiring the study of drugs, biological and nutritional(More)
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