Developing medicines for children requires a different scientific and regulatory strategy than adult drug development. Pediatric populations are smaller, physiology changes rapidly with age, and ethical constraints often limit traditional clinical trial designs.
At the same time, regulatory expectations continue to evolve. Global regulators increasingly expect quantitative evidence to support pediatric dose selection, extrapolation strategies, and study design. As a result, pharmacometrics and model-informed drug development (MIDD) have become central to modern pediatric development programs.
This expert guide explores the most common questions sponsors face when designing pediatric programs and how pharmacometric modeling helps address them.
In this guide, you will learn:
When sponsors should engage regulators on pediatric strategy
- How pharmacometrics supports pediatric dose selection and trial design
- Why MIDD is becoming a regulatory expectation in pediatric programs
- How modeling helps integrate adult, nonclinical, and limited pediatric data
- Where artificial intelligence and machine learning add value in pharmacometrics
- How to design pediatric programs that are scientifically defensible and regulator-ready
This guide is designed for clinical pharmacology, pharmacometrics, regulatory strategy, and translational science teams involved in pediatric drug development.
Drawing on insights from Certara experts and real industry discussions, this guide outlines how modeling and simulation enable more ethical, efficient, and scientifically grounded pediatric development programs.
