Industry Perspective on Using MIDD for Pediatric Studies Requiring Integration of Ontogeny

Abstract

Joining the Food and Drug Administration/University of Maryland Center of Excellence in Regulatory Science and Innovation Workshop to discuss and identify solutions to optimize pediatric drug development and, in particular, to address the question as to whether we are ready to incorporate pediatric ontogeny into modeling was the opportunity to share learnings, confront ideas, and present examples of studies performed in industry and academia. This was not only the opportunity to reflect on the experience and the knowledge so far within the current regulatory framework but also to look at the future and explore new and future approaches as well as best practices with the use of modeling and simulation and extrapolation as part of pediatric development.

Keywords: clinical pharmacology; clinical research; modeling and simulation; pediatrics; pharmaceutical R&D; pharmacodynamics; pharmacokinetics and drug metabolism; pharmacometrics; physiologically based pharmacokinetics (PBPK); regulatory/scientific affairs.