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Improving Predictive Modeling in Pediatric Drug Development: Pharmacokinetics, Pharmacodynamics, and Mechanistic Modeling
aOffice of Research and bDivision of Biometry and Risk Assessment, National Center for Toxicological Research/FDA, Jefferson, Arkansas, USA cCenter for Biological Monitoring and Modeling, Pacific Northwest National Laboratory, Richman, Washington, USA dCIIT, Centers for Health Research, Research Triangle Park, North Carolina, USA eBirth Defects Center, Systems Analysis Laboratory, University of Louisville, Louisville, Kentucky, USA fDepartment of Pharmacy Practice and Science, College of Pharmacy, University of Arizona, Tucson, Arizona, USA gDepartment of Chemical Engineering, University of Missouri-Columbia, Columbia, Missouri, USA hInstitute for Risk Analysis and Risk Communication, University of Washington, Seattle, Washington, USA iNational Institute of Child Health and Human Development, National Institutes of Health, Bethesda, Maryland, USA
Address for correspondence: William Slikker, Jr., Office of Research, National Center for Toxicological Research, 3900 NCTR Road, Jefferson, AR 72079-9502. Voice: 870-543-7950; fax: 870-543-7576. wslikker{at}nctr.fda.gov
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.
Key Words: PBPK • pharmacokinetics • pharmacodynamics • pediatrics • children • modeling
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