Improving predictive modeling in pediatric drug development: Pharmacokinetics, pharmacodynamics, and mechanistic modeling

William Slikker, John F. Young, Richard A. Corley, David C. Dorman, Rory B. Conolly, Thomas B. Knudsen, Brian L. Erstad, Richard H. Luecke, Elaine M. Faustman, Charles Timchalk, Donald R. Mattison

Research output: Contribution to journalArticle

7 Scopus citations

Abstract

A workshop was conducted on November 18-19, 2004, to address the issue of improving predictive models for drug delivery to developing humans. Although considerable progress has been made for adult humans, large gaps remain for predicting pharmacokinetic/pharmacodynamic (PK/PD) outcome in children because most adult models have not been tested during development. The goals of the meeting included a description of when, during development, infants/children become adultlike in handling drugs. The issue of incorporating the most recent advances into the predictive models was also addressed: both the use of imaging approaches and genomic information were considered. Disease state, as exemplified by obesity, was addressed as a modifier of drug pharmacokinetics and pharmacodynamics during development. Issues addressed in this workshop should be considered in the development of new predictive and mechanistic models of drug kinetics and dynamics in the developing human.

Original languageEnglish (US)
Pages (from-to)505-518
Number of pages14
JournalAnnals of the New York Academy of Sciences
Volume1053
DOIs
StatePublished - Jan 1 2005

Keywords

  • Children
  • Modeling
  • PBPK
  • Pediatrics
  • Pharmacodynamics
  • Pharmacokinetics

ASJC Scopus subject areas

  • Neuroscience(all)
  • Biochemistry, Genetics and Molecular Biology(all)
  • History and Philosophy of Science

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