"Pediatric Ontogeny: Ready for Incorporation into Modeling in Pediatric Drug Development?" will be held on Monday, Feb. 11, 2019, in the Great Room at the Food and Drug Administration, located at 10903 New Hampshire Ave., in Silver Spring, Md.
Modeling and simulation can reduce the numbers of pediatric patients to predict drug dose and effect, but such predictions rely on solid information on the ontogeny of the systems that interact with the new drug. The objectives of this workshop are to:
- Review the present state of knowledge of the ontogeny of systems critical to drug dosing and effect in pediatric patients.
- Discuss whether our knowledge of ontogeny of specific systems is adequate at the present time to make pediatric dosing and effect predictions through modeling and simulation.
- Identify pathways forward for acquiring the additional information needed for incorporating ontogeny into modeling and simulation predictions for pediatric new drug development.