OR WAIT 15 SECS
The agency released a draft reflection paper on the extrapolation of data from adults to children in the development of pediatric drugs.
The European Medicines Agency (EMA) has published a draft reflection paper on the extrapolation of clinical data from adults to children for the authorization of pediatric drugs. The paper outlines an approach to extrapolation of scientifically sound and reliable data from adults and other pediatric populations to support the authorization of a drug. This approach is proposed “to optimize the involvement of children in clinical studies … by predicting how a medicine may work in children and adolescents on the basis of studies conducted in adults or other pediatric populations.”
The extrapolation framework presented in the paper includes the following:
An EMA workshop on the extrapolation of data will be held May 17–18, 2016 to gather expert and stakeholder views. The draft reflection paper is scheduled to be released for public consultation at the end of July 2016.