Extrapolation of data from adults to children can facilitate development of paediatric medicines
The European Medicines Agency (EMA) has published a preliminary version of its draft reflection paper which outlines a framework for the extrapolation of clinical trial data from adults to children to support the authorisation of new medicines for children.
Extrapolation of data aims to optimise the involvement of children in clinical studies, one of the objectives of the European Union Paediatric Regulation, by predicting how a medicine may work in children and adolescents on the basis of studies conducted in adults or other paediatric populations.
The draft reflection paper outlines a systematic approach to extrapolation of data from adults or other paediatric populations to children that is considered scientifically sound and reliable to support the authorisation of a medicine. The framework sets out when, to what extent, and how extrapolation can be applied and validated.
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