Regulatory Science Needs for Neonates: A Call for Neonatal Community Collaboration and Innovation

[摘要] Neonates have long been a vulnerable population to unstudied therapies, starting as early as the late nineteenth century with Mrs. Winslow’s Soothing Syrup, a purported remedy for teething that contained alcohol and morphine sulfate, causing numerous infant deaths (1). In 1959, Gray baby syndrome was first reported in infants receiving large doses of chloramphenicol as a broad spectrum antibacterial agent (2), and in 1983, Mulhall et al. (3) noted the altered pharmacokinetics (PK) of chloramphenicol in neonates and young infants resulting in elevated serum levels and some toxic effects.

[学科分类] 儿科学

[关键词] neonatal;regulatory science;drugs;trials;collaboration