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 …

Introduction: Regulatory initiatives have stimulated drug research in infants, but the potential
impact of drugs to improve health outcome in neonates remains underexplored. Areas …

Background: Historically, neonatal therapeutic interventions were derived from adult
therapeutics, and tragedies resulting from this approach have demonstrated differences in …

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 …

Background Clinical trials are essential in neonates to evaluate scientifically the efficacy and
safety of drugs. However, major specificities condition clinical research in human neonates …

Knowledge about the safe and effective use of medicines in neonates has increased
substantially but has resulted in few label changes. Drugs developed for use in adults are …

Ensuring that children have access to safe and effective drugs has been a concern of
pediatricians for over 40 years. In 1977, the American Academy of Pediatrics Committee on …

Neonatal drug development is an area which deserves significant attention if we hope to
continue to improve outcomes. With the help of international collaborations, it is possible to …

Pharmacologic study is needed in the extremely immature newborns who currently survive.
Study is needed of both the drug treatment previously established in more mature neonates …

Developmental changes make the fetus and child uniquely susceptible to drug toxicities
which do not occur in mature individuals. Passive exposure to maternally administered …