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Physiologically based pharmacokinetic (PBPK) modeling in children.

J S Barrett1, O Della Casa Alberighi, S Läer

  • 1Department of Pediatrics, Division of Clinical Pharmacology & Therapeutics, The Children's Hospital of Philadelphia, Philadelphia, Pennsylvania, USA.

Clinical Pharmacology and Therapeutics
|June 7, 2012
PubMed
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Physiologically based pharmacokinetic (PBPK) modeling and simulation (M&S) is crucial for advancing pediatric drug research and development. This review highlights PBPK

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Area of Science:

  • Pharmacokinetics and Pharmacodynamics
  • Computational Biology and Bioinformatics
  • Pediatric Pharmacology

Background:

  • Pediatric drug development faces unique challenges due to physiological differences from adults.
  • Historically, PBPK methodologies were developed for toxicological assessments.
  • Evolving PBPK approaches are increasingly tailored for pediatric applications.

Purpose of the Study:

  • To review the current status of PBPK modeling and simulation (M&S) in pediatric drug research.
  • To elucidate the suitability of PBPK for pediatric drug development and pharmacotherapy.
  • To assess the confidence and key factors for adopting PBPK M&S in pediatric drug registration.

Main Methods:

  • Comprehensive literature review of PBPK modeling and simulation applications in pediatrics.
  • Analysis of the evolution of PBPK methodologies from toxicology to drug development.
  • Evaluation of factors influencing the confidence and adoption of pediatric PBPK M&S.

Main Results:

  • PBPK M&S is well-suited to address the complexities of pediatric drug development.
  • Significant advancements in pediatric PBPK methodologies enhance their applicability.
  • Confidence in using PBPK for pediatric drug development and registration is growing.

Conclusions:

  • PBPK M&S is a valuable tool supporting pediatric drug research, development, and registration.
  • Key factors for robust results and wider adoption include methodological advancements and validation.
  • Continued development and application of PBPK are essential for optimizing pediatric pharmacotherapy.