Developmental changes in children can affect the disposition and clinical effects of a drug,
indicating that scaling an adult dose simply down per linear weight can potentially lead to …

Introduction There is a need for structured approaches to inform on pharmacotherapy in
preterm neonates. With their proven track record up to regulatory acceptance …

Background Preterm neonates are usually not part of a traditional drug development
programme, however they are frequently administered medicines. Developing modelling …

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

Methods: In this study, several simple methods to project a first-in-pediatric dose to initiate a
clinical trial were evaluated. These methods were as follows:(1) Weight-based pediatric …

The objective of this study was to compare the predictive performance of an allometric model
with that of a physiologically based pharmacokinetic (PBPK) model to predict clearance or …

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 …

Background Finerenone is a nonsteroidal selective mineralocorticoid receptor antagonist
that recently demonstrated efficacy in delaying chronic kidney disease progression and …

Clinical Pharmacology During Pregnancy, Second Edition is written for clinicians,
physicians, midwives, nurses, pharmacists and other medical professionals involved in the …

This study aims to explore and characterize the role of pediatric sedation via rectal route. A
pediatric physiologically based pharmacokinetic-pharmacodynamic (PBPK/PD) model of …