Dose Finding in the Clinical Development of 60 US Food and Drug Administration-Approved Drugs Compared With Learning vs. Confirming Recommendations

• Main Authors: Yassine Kamal Lyauk (Author), Daniël Martijn Jonker (Author), Trine Meldgaard Lund (Author)
• פורמט: ספר
• יצא לאור: Wiley, 2019-09-01T00:00:00Z.
• נושאים: article
• גישה מקוונת: Connect to this object online.

This review characterizes clinical development that supported the label dose in 60 drug indications recently approved by the US Food and Drug Administration. With Lewis B. Sheiner's Learning vs. Confirming clinical drug development paradigm as a reference point, the clinical development paths,...