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Children Are Not Small Adults, but Can We Treat Them As Such?

Elke H J Krekels1, Elisa A M Calvier1, Piet H van der Graaf1,2

  • 1Division of Systems Biomedicine and Pharmacology, Leiden Academic Center of Drug Research, Leiden University, Leiden, The Netherlands.

CPT: Pharmacometrics & Systems Pharmacology
|January 29, 2019
PubMed

Insights

Linear scaling of drug plasma clearance (CLp) is accurate for pediatric patients down to 1 month for glomerular filtration and 2 years for hepatic clearance, suggesting they can often be treated as small adults.

Area of Science:

  • Pharmacokinetics and Drug Metabolism
  • Pediatric Pharmacology
  • Physiologically Based Pharmacokinetic (PBPK) Modeling

Background:

  • Pediatric drug dosing presents challenges due to nonlinear pharmacokinetic processes in children.
  • Current pediatric dosing often relies on weight-based (per kilogram) calculations, assuming children are small adults.
  • Allometric scaling (AS 0.75) is a common method for extrapolating adult drug clearance to pediatric populations.

Purpose of the Study:

  • To evaluate the accuracy of linear scaling of plasma clearance (CLp) in pediatric patients across different age groups.
  • To compare linear scaling with fixed allometric scaling (AS 0.75) for hypothetical drugs with varying parameters.
  • To determine the reliability of treating pediatric patients as small adults for drug clearance estimations.

Main Methods:

  • A physiologically based pharmacokinetic (PBPK) workflow was employed to model drug clearance.
  • Hypothetical drugs with a range of realistic parameter values were simulated in pediatric patients of various ages.
  • Linear CLp scaling and fixed allometric scaling (AS 0.75) were compared against PBPK model outputs.

Main Results:

  • Linear CLp scaling demonstrated accuracy down to 1 month of age for drugs cleared by glomerular filtration, with exceptions for highly alpha-1-acid glycoprotein (AGP)-bound drugs.
  • For hepatically cleared drugs, linear scaling was accurate down to 2 years of age, except for AGP-bound drugs with low extraction ratios and mature isoenzymes.
  • In neonates, linear scaling outperformed AS 0.75 for drugs bound to human serum albumin (HSA) and AGP that undergo glomerular filtration.

Conclusions:

  • Linear scaling of plasma clearance is a reliable method for pediatric drug dosing in many scenarios.
  • The findings support the concept that pediatric patients can be considered small adults for drug clearance estimations in numerous cases.
  • Exceptions to linear scaling accuracy highlight the importance of drug-specific properties like protein binding and metabolic pathways.

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