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The European Medicines Agency Experience With Pediatric Dose Selection
Author(s) -
Manolis Efthymios,
Musuamba Flora T.,
Karlsson Kristin E.
Publication year - 2021
Publication title -
the journal of clinical pharmacology
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 0.92
H-Index - 116
eISSN - 1552-4604
pISSN - 0091-2700
DOI - 10.1002/jcph.1863
Subject(s) - agency (philosophy) , selection (genetic algorithm) , regimen , pediatric research , medicine , risk analysis (engineering) , intensive care medicine , medical education , psychology , computer science , pediatrics , sociology , machine learning , social science
Getting the right dose regimen for children and adolescents is important but poses great scientific, practical, and ethical challenges. At the same time, the availability of data in adults is a huge advantage and needs to be used optimally when designing studies in children and analyzing pediatric data. Furthermore, the processes of maturation and growth are always key when selecting doses for children. All the above make study adaptations and model‐informed approaches imperative for dose exposure‐response characterization and dose selection in children. This article summarizes the experience gained in the European Medicines Agency on this topic and proposes some general guiding principles for defining objectives, study designs, and methodology tools for pediatric dose selection.