• Karel Allegaert.
• University Hospitals Leuven, Neonatal Intensive Care Unit , Herestraat 49, 3000 Leuven , Belgium +32 16 343850 ; +32 16 343209 ; karel.allegaert@uzleuven.be.
• Expert Opin Drug Metab Toxicol. 2014 Aug 1;10(8):1069-78.

IntroductionExtensive within-population variability is the essence of neonatal pharmacology. Despite this, infants remain one of the last therapeutic orphans. Together with additional legal initiatives, tailoring of already available tools (modeling, covariates, pharmacovigilance) may significantly improve pharmacotherapy in infants.Areas CoveredModeling approaches that hold the promise to improve pharmacotherapy in infants are between-compound extrapolation for compounds that undergo the same route of elimination and integration of time-varying physiology to adapt for the fast maturational changes. Besides these maturational covariates (size, age), newly emerging covariates relate to novel treatment modalities (extracorporeal circulation, hypothermia), environmental issues (microbiome, critical illness) or pharmacogenetics. All these covariates interact with the maturational variation. Finally, pharmacovigilance also needs to be tailored to the characteristics of this population. This relates to preventive strategies, signal detection and assessment of causality.Expert OpinionKnowledge on pharmacotherapy in infants is lagging. Tailoring available tools to the specific characteristics (maturation) and clinical needs (newly emerging covariates) of infants is feasible but needs creativity and a multidisciplinary collaboration between modelers, academia, clinical researchers and, obviously, the public, including parents.

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