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Improving Predictive Modeling in Pediatric Drug Development: Pharmacokinetics, Pharmacodynamics, and Mechanistic Modeling
Author(s) -
SLIKKER WILLIAM,
YOUNG JOHN F.,
CORLEY RICHARD A.,
DORMAN DAVID C.,
CONOLLY RORY B.,
KNUDSEN THOMAS B.,
ERSTAD BRIAN L.,
LUECKE RICHARD H.,
FAUSTMAN ELAINE M.,
TIMCHALK CHARLES,
MATTISON DONALD R.
Publication year - 2005
Publication title -
annals of the new york academy of sciences
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 1.712
H-Index - 248
eISSN - 1749-6632
pISSN - 0077-8923
DOI - 10.1111/j.1749-6632.2005.tb00061.x
Subject(s) - pharmacokinetics , drug development , pharmacodynamics , drug , medicine , pharmacology , intensive care medicine
A bstract : 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.