A Modeling and Simulations Framework to Support Global Regulatory Strategies for Pediatric Drug Development Programs.

Abstract

Trial simulations have emerged as a promising tool to optimize pediatric drug development programs. As the current FDA legislation on pediatric drugs and devices was updated to mirror the EMA legislation, pediatric programs must be developed with global strategies that support a Pediatric Investigation Plan (PIP) for the EMA and a Pediatric Study Plan (PSP) for the FDA. A pharmacometrics framework is proposed to support global regulatory strategies for pediatric drug development programs. The framework describes specific trigger points and opportunities for applying modeling and simulation techniques to design the PIP and PSP and ultimately optimize pediatric drug development programs. The development of pediatric protocols by simulations and execution plans is deemed critical in defining expectations and ensuring the future success of these global programs. This can lead to clinical trial designs that are more efficient, less prone to failure, and ultimately, less costly.