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Model-based DDI Extrapolation Strategy from Adults to Children – A Case Study with Risdiplam

Live webinar

Risdiplam (EVRYSDI) is approved for the treatment of patients with spinal muscular atrophy ≥ 2 months old. CYP3A-mediated DDI risk in pediatric patients was evaluated by physiologically-based pharmacokinetic (PBPK) modelling and informed the label.

This talk will illustrate a modeling strategy for the extrapolation of DDIs from adults to children covering:

  • Development of a patient-specific growth model
  • Validation of the adult PBPK model with independent data
  • Estimation of drug specific DDI parameters from clinical data in healthy adults
  • Sensitivity assessments of different ontogeny functions for DDI extrapolations from adults to children
  • Approach to qualify DDI prediction in children
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Speakers
Yumi Cleary
Clinical Pharmacometrician, Roche
Michael Gertz
Senior Principal Scientist, Roche
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