AUTHOR=Yeung Cindy Hoi Ting , Verstegen Ruud H. J. , Greenberg Rachel , Lewis Tamorah Rae TITLE=Pharmacokinetic and pharmacodynamic principles: unique considerations for optimal design of neonatal clinical trials JOURNAL=Frontiers in Pediatrics VOLUME=11 YEAR=2024 URL=https://www.frontiersin.org/journals/pediatrics/articles/10.3389/fped.2023.1345969 DOI=10.3389/fped.2023.1345969 ISSN=2296-2360 ABSTRACT=

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 selection, pharmacokinetics, pharmacogenetics and pharmacodynamics that stakeholders may consider when undertaking a neonatal or infant clinical trial.