www.fdanews.com/articles/176074-ema-spells-out-data-extrapolation-plan-for-pediatric-drug-development
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EMA Spells Out Data Extrapolation Plan for Pediatric Drug Development
April 8, 2016
The European Medicines Agency is recommending that sponsors use clinical trial information from adults to support the development of therapies for children.
Because it’s difficult to enroll children in clinical trials, and there is a “reasonable similarity” between adults and children, the agency laid out an extrapolation framework as a baseline to help drugmakers reduce the number of pediatric patients in clinical trials.
The paper aims to help sponsors determine appropriate doses in the various age groups along with safety, efficacy and benefit-risk balance information in children.