Using PK/PD M&S for Pediatric Drug Development: Regulatory Insights into Practical Issues

This webinar will review common issues that occur in regulatory submissions of modeling and simulation data for drugs for pediatric populations. With the greater importance placed on pediatric trials and the data obtained from them, this webinar will address some of the challenges associated with pediatric drug development and the advantages (and limitations) that pediatric population PK modeling can provide. Our speakers, Drs. Nastya Kassir and Justin Pittaway-Hay will provide an overview of the regulatory perspectives into common issues that are raised during regulatory submissions of M&S data for pediatric populations. By attending this webinar, you will learn the following:

  • How to implement weight and organ maturation in population PK modeling and simulation
  • Best practices for dose selection and allometric scaling
  • How to use modeling and simulation to support extrapolation and the presentation of data and results
Speaker(s): Justin Pittaway & Nastya Kassir
Date: November 20, 2019
Time: 11:00 am ET
Duration: 1 hour
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