Optimal Sample Size for Use in Neonatal Pharmacokinetic Studies.

Bo-Hao TangBu-Fan YaoJohn van den AnkerWei Zhao

Published in: Therapeutic innovation & regulatory science (2022)

A sample size of 25 neonates provided a consistent estimation of the overall population (PMA: 23.3-52.4 weeks) clearance for a drug with high individual variability using a sparse PK sampling design. A sample size of 50 was recommended to complete neonatal age sub-group assessments.

Keyphrases

emergency department
low birth weight
case control
preterm infants