Author’s Reply to Standing et al. Pharmacokinetic Studies in Neonates: The Utility of an Opportunistic Sampling Design

Excerpt

The rational use of medicines in neonates is limited by the absence of scientific evidence, and the off-label use of drugs is a critical issue in neonatal clinical practice; therefore, the need for properly designed and conducted neonatal clinical trials has never been greater. The dramatic physiologic and maturation processes during the first month of life produce dynamic alterations in drug pharmacokinetics. To effectively optimize drug therapy in neonates, a thorough understanding of developmental pharmacokinetics is essential. The major barriers to neonatal pharmacokinetic studies are related to pharmacokinetic sampling, including the relatively large volumes of blood loss during a study period, the difficulty in timing pharmacokinetic samples owing to the critical clinical condition of the infants, the difficulty in access to samples, and the low rate of informed parental consent [1]. This challenge is more apparent in preterm infants. …