Safety, Dosing, and Pharmaceutical Quality for Studies that Evaluate Medicinal Products (including Biological Products) in Neonates KU Leuven
The study of medications among pediatric patients has increased worldwide since 1997 in response to new legislation and regulations, but these studies have not yet adequately addressed the therapeutic needs of neonates. Additionally, extant guidance developed by regulatory agencies worldwide does not fully address the specificities of neonatal drug development, especially among extremely premature newborns who currently survive. Consequently, an ...