What’s Effective and Safe?
Children are not small adults. If drugs are first tested on adults, and they usually are, how do we know how much is too much for children? An article in Statistics in Medicine brings up these important questions for discussion. In it, researchers “propose a model based on a non‐parametric regression method called Gaussian process (GP) to detect deviations from the made extrapolation assumptions. The results show that the GP approach can reliably detect maturation trends from sparse pediatric data.” First author of the study, Eero Siivola, comments, “Kids’ organs are simply not as efficient as those of adults. In drug modeling, if we assume that size is the only thing that matters, we might end up giving too large of doses.”
The study concludes that “we have shown that a non‐parametric GP approach can reliably detect whether dosing regimen adjustments are needed or if the chosen dosing regimen is adequate. In comparison to model checking approaches, which rely on possibly subjective evaluation of model diagnostics, the proposed GP approach is data‐driven and thus less subjective. In addition to this, GPs avoid bias and overconfident conclusions when compared to parametric approaches. Overall, the presented GP approach can lead to better decisions in pediatric drug development.”
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