The ICH E11A Guideline on paediatric extrapolation reached Step 5 on 21 August 2024, following the public consultation of its draft version in 2022. The primary aim of this guideline is to promote the international harmonisation of paediatric extrapolation to support the development and authorisation of paediatric medicines. To achieve this goal, the guideline provides a framework of recommendations for applying extrapolation in paediatric drug development. This includes aligning terminology related to paediatric extrapolation, offering a systematic approach to its use, and covering aspects such as study designs, statistical analysis, modelling and simulation and related methods.
Following the public consultation, no major changes were made to the content. However, minor revisions were introduced to enhance clarity and provide more detailed information. Discover more here.