Pharmacokinetic and pharmacodynamic principles: unique considerations for optimal design of neonatal clinical trials

Cindy Hoi Ting Yeung; Ruud H J Verstegen; Rachel Greenberg; Tamorah Rae Lewis

doi:10.3389/fped.2023.1345969

Pharmacokinetic and pharmacodynamic principles: unique considerations for optimal design of neonatal clinical trials

Front Pediatr. 2024 Jan 12:11:1345969. doi: 10.3389/fped.2023.1345969. eCollection 2023.

Authors

Cindy Hoi Ting Yeung¹, Ruud H J Verstegen^{1

2}, Rachel Greenberg^{3

4}, Tamorah Rae Lewis^{1

2}

Affiliations

¹ Division of Clinical Pharmacology and Toxicology, The Hospital for Sick Children, Toronto, ON, Canada.
² Department of Pediatrics, University of Toronto, Toronto, ON, Canada.
³ Duke Clinical Research Institute, Durham, NC, United States.
⁴ Department of Pediatrics, Duke University School of Medicine, Durham, NC, United States.

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.

Keywords: clinical trial; dose; neonate; pharmacodynamic; pharmacogenetic; pharmacokinetic.

Publication types

Review

Grants and funding

The author(s) declare that no financial support was received for the research, authorship, and/or publication of this article.