The E11A Guideline provides recommendations and promotes international harmonisation of paediatric extrapolation to support the development and authorisation of paediatric medicines. The E11A Guideline
provides a framework for using extrapolation to support paediatric drug development. The framework describes an iterative process for understanding the existing information available, the gaps in information needed to inform development, and ways to generate additional information when required and recommends approaches to assessing factors that influence the determination of similarity of disease, drug pharmacology, and response to treatment between a reference and paediatric target population. In addition, it discusses how the characteristics of the disease, drug pharmacology and response to treatment may influence this determination…
