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Physiologically‐based pharmacokinetic models are increasingly applied for pediatric dose selection along with traditional methods such as allometry and population pharmacokinetic models. We report a retrospective evaluation of the three methods. Pediatric population pharmacokinetic models sourced from literature for a subset of eight compounds were used to predict clearances for children < 2 years when they were within the modeled age range (interpolation,  N  = 11) or including those outside the modeled age range (interpolation and extrapolation,  N  = 18). Pediatric/adult clearance ratios were evaluated with a strict performance criterion of 0.8–1.25 and with twofold criteria. For children > 2 years, 58–75% of the clinical studies ( N  = 10) met the strict criteria, and > 80% of the clinical studies were predicted within twofold by all three methods. For children < 2 years,  physiologically‐based pharmacokinetic , allometry with age‐dependent exponents, and pediatric population pharmacokinetic models predict 54%, 82%, and 64% within twofold of the observed, respectively.

cpt: pharmacometrics and systems pharmacology

A Retrospective Evaluation of Allometry, Population  Pharmacokinetics,  and  Physiologically‐Based Pharmacokinetics  for Pediatric Dosing Using Clearance as a Surrogate