The number of clinical trials with medicine in children is very low compared to the therapeutic need.The need for an increase of paediatric clinical studies has been recognized both by the FDA, as early as 2002, and by EMA, with the entry into force in 2007 of the European Regulation on paediatric medicines.
La sperimentazione clinica con medicinali in Pediatria: a che punto siamo?
LEONE, Roberto
2016-01-01
Abstract
The number of clinical trials with medicine in children is very low compared to the therapeutic need.The need for an increase of paediatric clinical studies has been recognized both by the FDA, as early as 2002, and by EMA, with the entry into force in 2007 of the European Regulation on paediatric medicines.
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