Designing a Pediatric Development Plan (PIP/PSP) that satisfies regulatory requirements while remaining agile and cost-effective is one of the most complex challenges in drug development today. This is especially true in competitive therapeutic areas such as weight management, where speed to market is critical.
In this Read the Regulatory Insight, PLG’s regulatory strategy team and Model Informed Drug Development (MIDD) experts illustrate how PK/PD modelling can be leveraged to minimize the number of pediatric patients needed in clinical trials – without compromising on safety or efficacy – by extrapolating adult data to pediatric populations in a scientifically rigorous and regulatorily acceptable way.
From dose selection in adolescents and children, to deferral strategies and interactions with EMA and FDA, this example walks through a practical, end-to-end approach to building a robust PIP/PSP.

See how MIDD can streamline your Pediatric Development Plan
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PK/PD Modelling as a Strategic Driver for Pediatric Development Plans