Applications of physiologically based pharmacokinetic (PBPK) models for pediatric populations

Abstract

Given the difficulties for conducting clinical studies in infants and children, pediatric pharmacometrics, which applies quantitative models to account maturation of biochemical and physiological aspects of development, to predict efficacy and the likelihood of adverse reactions, is being extensively applied during pediatric drug development. More specifically, pharmacokinetics, pharmacodynamics, and disease are evaluated in different subpopulations using different methodologies. Both the European Medicines Agency (EMA) and the FDA’s pharmacometrics initiative have influenced pediatric clinical design [41, 45]. Many pediatric pharmacometric examples are for drugs already on the market but used off-label in children to address the concerns on age-appropriate dose, efficacy, and safety in this special population.