Can Pediatric Dosing be Extrapolated From Adult Dosing? FDA Suggests Ways
Conducting clinical trials in children is extremely challenging so very few drugs are tested and approved based on pediatric clinical trials. Pediatricians frequently guesstimate dosing for their patients based on subjective assessment of the dosing data approved for adults. However, there might be an FDA-acceptable statistical methodology for formal extrapolation of adult doses to children … Read more