Enhancing paediatric drug development in PH: extrapolation from adult data

Presented at PVRI 2026 Congress by Sylvia Nikkho, Bayer AG

Summary

Drug development for paediatric PH focuses on understanding the differences between adult and child diseases, addressing regulatory challenges, and the need for extrapolation. It requires strong adult data, careful paediatric endpoints, and collaboration with regulatory bodies. Tailored approaches are essential for trials, ensuring safety and efficacy while reducing exposure to experimental drugs. Innovative strategies and patient involvement are crucial in this process.

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