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The Utility of Pharmacometric Models in Clinical Pharmacology Research in Infants
Journal article   Open access   Peer reviewed

The Utility of Pharmacometric Models in Clinical Pharmacology Research in Infants

Guohua An
Current pharmacology reports, Vol.6(5), pp.260-266
2020
DOI: 10.1007/s40495-020-00234-5
PMCID: PMC7987099
PMID: 33767946
url
http://europepmc.org/pmc/articles/PMC7987099View
Open Access

Abstract

Purpose of Review Acquiring knowledge on drug disposition and action in infant is challenging because of the problem of sparse and unbalanced data obtained for each individual infant due to the limited blood volume as well as the issue of extensive intersubject and intrasubject variability in drug exposure and response due to the fast growth and dynamic maturation changes in infants. This commentary highlights the importance of using population-based pharmacometric models to improve knowledge on drug disposition and action in infants. Recent Findings Pharmacometric modeling remains to be critical in clinical pharmacology research in infants. Many pediatric covariate models developed for scaling of drug clearance use a combination of allometric weight scaling to account for size change and a sigmoid function of antenatal development and postnatal maturation to characterize the age-related maturation. To expedite the development of safe and effective dosing regimens in infants, a number of strategies have been proposed recently, including the use of pediatric covariate model obtained from one drug for extrapolation to other drugs undergoing similar elimination pathways, as well as the combination of opportunistic clinical studies and population-based pharmacometric models. Summary Population-based pharmacometric modeling plays a pivotal role in clinical pharmacology research in infants. Most of the covariate models reported so far focus on antibiotics undergoing renal elimination. Novel modeling strategies have been proposed recently to facilitate clinical pharmacology research and expedite the dose optimization process in infants.
 Biomedical and Life Sciences Biomedicine Cancer Research General Molecular Medicine Pharmacology/Toxicology Pharmacometrics and Quantitative System Pharmacology (S Woo Section Editor Topical Collection on Pharmacometrics and Quantitative System Pharmacology

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