Selection of the first dose for neonates in clinical trials is very challenging. The objective of this analysis was to assess if a population pharmacokinetic (PopPK) model developed with data from infants to adults is predictive of neonatal clearance, and to evaluate what age range of prior PK data are needed for informative modeling to predict neonate exposure. Two sources of pharmacokinetic data from 8 drugs were used to develop population models: i) data from all patients > 2 years of age, and ii) data from all non-neonatal patients aged >28 days. The prediction error based on the models using data from subjects > 2 years of age showed bias towards over prediction with median average fold error (AFE) for CLpredicted/CLobserved greater than 1.5. The bias for predicting neonatal PK was improved when using all prior PK data including infants as opposed to an assessment without infant PK data, with the median AFE 0.91. As an increased number of pediatric trials are conducted in neonates under FDASIA, dose selection should be based on the best estimates of neonatal pharmacokinetics and pharmacodynamics prior to the conduct of efficacy and safety studies in neonates.