Clinical and Translational Science,

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

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, the design of dose‐ranging trials, and the dose–exposure–response characterization were examined using US Food and Drug Administration approval packages. It was found that 89% of clinical development programs...

Clinical and Translational Science

Sat Jun 29, 2019 15:07