Frontiers in Pediatrics (Jan 2024)

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

  • Cindy Hoi Ting Yeung,
  • Ruud H. J. Verstegen,
  • Ruud H. J. Verstegen,
  • Rachel Greenberg,
  • Rachel Greenberg,
  • Tamorah Rae Lewis,
  • Tamorah Rae Lewis

DOI
https://doi.org/10.3389/fped.2023.1345969
Journal volume & issue
Vol. 11

Abstract

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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