Paediatric Extrapolation - Opportunities and Challenges
Swedish Medical Products Agency
In recent years paediatric extrapolation has been brought forward as a key approach to modernise paediatric drug development. In the EMA Paediatric Extrapolation Reflection Paper (2018) and the upcoming ICH E11A guideline the extrapolation strategy has been divided into Extrapolation Concept and Extrapolation Plan, in short, how to justify the extrapolation approach and what to be studied. The more structured extrapolation approach provides an opportunity to compile a paediatric drug development program based on extrapolation, and at the same time pinpoint the challenges in doing so. This presentation will highlight some of the opportunities and challenges in modern paediatric extrapolation.