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 …

Due to complex maturational and physiological changes that characterize neonates and
affect their response to pharmacological treatments, neonatal pharmacology is different from …

The comparative performances of physiologically‐based pharmacokinetic (PBPK) modeling
and allometric scaling for predicting the pharmacokinetics (PKs) of large molecules in …

The objective of this study was to evaluate the predictive performance of population models
to predict renal clearance in newborns and infants. Pharmacokinetic (PK) data from eight …

An understanding of pediatric pharmacokinetics (PK) is essential for first‐in‐pediatric dose
selection and clinical trial design. At present, there is no reliable way to scale the PK of …

Introduction: The neonatal population remains one of the populations in which appropriate
dosing regimens are still lacking, resulting in a large off-label or unlicensed use. Clinical …

Core clinical pharmacology principles must be considered when designing and executing
neonatal clinical trials. In this review, the authors discuss important aspects of drug dose …

Evidence for dosing, efficacy, and safety of most medications used to treat neonates is
sparse. Thus, dosing is usually derived by extrapolation from adult and pediatric …

Antibiotics are invaluable in the management of neonatal infections. However, overuse or
misuse of antibiotics in neonates has been associated with adverse outcomes, including …

Purpose There is a need for alternative analgosedatives such as dexmedetomidine in
neonates. Given the ethical and practical difficulties, protocol design for clinical trials in …