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

FDA, sequential clinical development, drug approvals, clinical trials, dosages

This review evaluates the current practice of dose finding in the pharmaceutical industry and assesses the clinical evidence supporting the optimality of the label dose. Previous work has focused on dose-ranging trial design, while clinical development paths and dose–exposure–res…

Jun 29^th • 15 mins read