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Physiologically Based Pharmacokinetic Modeling in Neonates: Current Status and Future Perspectives

Wei Zhang1, Qian Zhang1, Zhihai Cao1

  • 1Department of Clinical Pharmacology, The Second Affiliated Hospital of Anhui Medical University, Hefei 230601, China.

Pharmaceutics
|December 23, 2023
PubMed

Insights

Neonates require careful drug dosing due to physiological immaturity. Physiologically based pharmacokinetic (PBPK) modeling aids in predicting drug concentrations and optimizing dosages for this vulnerable population.

Area of Science:

  • Pharmacology
  • Pediatrics
  • Computational Biology

Background:

  • Neonates exhibit unique physiological differences impacting drug absorption, distribution, metabolism, and excretion.
  • Accurate drug dosing in neonates is critical to ensure therapeutic efficacy and prevent toxicity.
  • Traditional clinical trials in neonates are challenging due to ethical and practical considerations.

Purpose of the Study:

  • To review age-dependent physiological factors influencing neonatal pharmacokinetics.
  • To explore the application of physiologically based pharmacokinetic (PBPK) modeling in neonatal drug development.
  • To discuss future perspectives for PBPK modeling in neonatal care.

Main Methods:

  • Literature review of studies on neonatal physiological changes affecting drug disposition.
  • Analysis of PBPK modeling applications in pediatric pharmacology.
  • Synthesis of current research on PBPK model verification and utility.

Main Results:

  • PBPK models can predict drug plasma concentrations in newborns, compensating for clinical trial limitations.
  • These models provide valuable insights for designing neonatal clinical research.
  • PBPK modeling has been successfully applied to various medications in neonatal studies.

Conclusions:

  • PBPK modeling is a powerful tool for optimizing drug therapy in neonates.
  • Further development and application of PBPK models are crucial for advancing neonatal pharmacotherapy.
  • This approach enhances rational drug use in this vulnerable population.

Keywords:
PBPKmodeling and simulationpreterm infantsterm infants

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