Neonatal and Juvenile Toxicology Testing

Scientists at Charles River have successfully assisted in the design, performance and planning of appropriate neonatal and juvenile toxicology testing programs to support registration of pediatric use of pharmaceuticals and biopharmaceuticals (including vaccines).

Over the past two decades, we have performed hundreds of rodent studies and over 50 nonrodent studies in neonatal and juvenile animals with a complete spectrum of evaluations and dose routes ranging from inhalation to intravenous infusion. We can also perform studies in farm piglets to evaluate additives to baby formula.

Study Design Considerations

  • Intended population or likely use of the drug in children
  • Species selection, age, sex and sample size
  • Novel pediatric formulations
  • Timing of dosing, exposure and monitoring in relation to phase of growth and development in pediatric populations and juvenile animals
  • Potential differences in pharmacological and toxicological profiles between mature and immature systems
  • Selection of toxicological and organ system endpoints

Evaluations

  • Nervous system
  • Immune system
  • Other organ systems (renal, cardiovascular, gastroinstestinal, pulmonary)
  • Reproductive system
  • Skeletal system (growth)
  • Routine toxicology endpoints (e.g., clinical pathology, metabolic system, histopathology)
  • Juvenile safety pharmacology (neurobehavioral, pulmonary, cardiovascular)

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