Should a pharmacokinetic model be more than its data?

The authors investigate whether pharmacokinetic models should extend beyond merely fitting observed data to effectively predict drug behavior in diverse populations, particularly in pediatric drug development. They emphasize the importance of incorporating allometry and maturation in modeling to ensure reliable extrapolation of drug clearance predictions, which is crucial for safe and evidence-based dosing. The study highlights that models grounded in physiological principles not only meet regulatory standards but also enhance the credibility of predictions across different demographic groups.