Adequacy of safety data for regulatory approval of pediatric indication through extrapolation algorithm.

Abstract

https://tcpharm.org This commentary deals with the realistic difficulty arising from the haziness as to what safety data should mean, especially for regulatory authorities to feel confident that approval of new drug indications for pediatric populations could be endowed, and when you were guided that complete extrapolation of adult efficacy data would be possible with an additional pharmacokinetic (PK) study, but safety data cannot be extrapolated.