Improving predictive modeling in pediatric drug development: pharmacokinetics, pharmacodynamics, and mechanistic modeling.
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 adult-like 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.
Slikker
William
W
Office of Research, National Center for Toxicological Research/FDA, 3900 NCTR Road, Jefferson, Arkansas 72079-9502, USA. wslikker@nctr.fda.gov
Young
John F
JF
Corley
Richard A
RA
Dorman
David C
DC
Conolly
Rory B
RB
Knudsen
Thomas B
TB
Erstad
Brian L
BL
Luecke
Richard H
RH
Faustman
Elaine M
EM
Timchalk
Charles
C
Mattison
Donald R
DR
D000328:Adult; D002648:Child; D019295:Computational Biology; D003952:Diagnostic Imaging; D006801:Humans; D007223:Infant; D007231:Infant, Newborn; D008954:Models, Biological; D009765:Obesity / Q000188:drug therapy / Q000503:physiopathology; D010599:Pharmacokinetics; D010600:Pharmacology; D011237:Predictive Value of Tests