EMA RELEASES PAPER ON USING ADULT MEDICINE DATA TO DEVELOP CHILD MEDICINES
April 1st, 2016
THE EUROPEAN Medicines Agency (EMA) has released a paper that proposes how pharmacos and regulators could accept extrapolated data from adult subjects when developing pharmaceuticals targeted at children. Its guidance is designed to “ensure harmonised and consistent decision making along the product development life cycle regarding the use of extrapolation in paediatric population,” said the report’s conclusion. “This should result in a more rational, consistent, and more efficient paediatric drug development, and a better targeting of paediatric ...
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