Pre-clinical considerations for initiating pediatric trials - case study

• DRUG 1

  • Segment 3: (+) impaired cognitive fxn. in offspring
  • Genotoxicity: (+)
  • Adults: peripheral neuropathy
  • Pediatric trials delayed

• DRUG 2

  • Acute toxicity: (-)
  • Segment 3: (-)
  • Genotoxicity: (-)
  • Pediatric trials early in drug development

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