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Comparison of Approved Dosages for Pediatric and Adult Populations Based on US Labeling Information

Keizo Hanada1, Masayuki Kaneko1, Mamoru Narukawa1

  • 11 Graduate School of Pharmaceutical Sciences, Department of Clinical Medicine (Pharmaceutical Medicine), Kitasato University, Tokyo, Japan.

Therapeutic Innovation & Regulatory Science
|September 18, 2018
PubMed

Insights

Pediatric drug dosages based on body weight (BW) were higher than adult doses, while body surface area (BSA) dosages were similar. Age proximity strongly correlates relative pediatric drug dosages.

Area of Science:

  • Pharmacology
  • Pediatric Medicine
  • Drug Development

Background:

  • Recent legislation in the US and EU mandates pediatric drug dosage approvals.
  • This necessitates understanding factors influencing pediatric dose selection.

Purpose of the Study:

  • To identify key factors in selecting appropriate drug dosages for pediatric populations.
  • To analyze the relationship between pediatric and adult drug dosages based on different metrics.

Main Methods:

  • Utilized the FDA's New Pediatric Labeling Information Database.
  • Standardized drug labels for pediatric age groups (6 months, 2, 6, 11 years) by age, body weight (BW), and body surface area (BSA).
  • Calculated pediatric-to-adult dosage ratios for 108 drugs.

Main Results:

  • Pediatric dosages normalized by BW exceeded adult dosages (ratios > 1).
  • Pediatric dosages normalized by BSA were comparable to adult dosages (ratios ≈ 1).
  • Relative dosages at 6 months showed a stronger correlation with 2-year-olds' dosages than with other age groups.

Conclusions:

  • Approved pediatric drug dosages based on BW are higher than adult dosages.
  • Approved pediatric drug dosages based on BSA are similar to adult dosages.
  • Closer age groups exhibit stronger correlations in relative drug dosages.
Abstract

Keywords:
efficacylabelingpediatric dosingpediatric drugspharmacokineticssafety

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