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Pediatric Age Groups and Approach to Studies

Kathleen M Job1, Margaret Gamalo2, Robert M Ward1

  • 11 Division of Clinical Pharmacology, Department of Pediatrics, University of Utah, Salt Lake City, UT, USA.

Therapeutic Innovation & Regulatory Science
|July 18, 2019
PubMed

Insights

Pediatric clinical trials should select age ranges reflecting rapid pharmacokinetic and pharmacodynamic changes. This ensures optimal drug study design based on age-related metabolic and filtration alterations in children.

Area of Science:

  • Pharmacology
  • Pediatric Medicine
  • Clinical Trials

Background:

  • Pediatric clinical trials frequently specify age ranges for participation.
  • Historically, these ages align with developmental stages like infancy and adolescence.
  • Current practices often select ages based on developmental milestones rather than physiological changes.

Purpose of the Study:

  • To emphasize the importance of selecting pediatric age ranges based on physiological changes relevant to drug disposition.
  • To highlight the need for age-specific pharmacokinetic and pharmacodynamic considerations in pediatric medication studies.

Main Methods:

  • Review of age-related changes in drug metabolism enzymes.
  • Analysis of age-dependent alterations in glomerular filtration rates.
  • Correlation of these physiological changes with optimal age selection for pediatric drug studies.

Main Results:

  • Significant age-related variations exist in enzymes crucial for drug metabolism.
  • Glomerular filtration rates exhibit substantial changes across pediatric developmental stages.
  • These physiological shifts indicate specific optimal age windows for studying particular drug disposition pathways.

Conclusions:

  • Age selection in pediatric trials must prioritize periods of rapid pharmacokinetic and pharmacodynamic shifts.
  • Understanding age-related changes in drug metabolism and excretion is vital for accurate pediatric medication studies.
  • Tailoring trial ages to physiological development optimizes the study of drug disposition in pediatric populations.

Keywords:
developmental drug metabolismdevelopmental renal functionpediatric clinical trialspediatric pharmacologyperinatal drug metabolism

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