Applications of Adaptive Designs in Generic Drug Development

The possibilities of stopping a clinical study earlier based on interim study results or to adjust the sample size during the study conduct are attractive features of adaptive clinical study designs. Herein, we present a survey summary of bioequivalence (BE) studies with adaptive designs in abbreviated new drug applications (ANDAs), reflecting the current status of its utility in generic drug development.

Automated summary

The advantages of adaptive clinical study designs, such as stopping a study early based on interim results or adjusting sample size, are appealing. A survey of bioequivalence studies with adaptive designs in abbreviated new drug applications (ANDAs) is presented, demonstrating the utility of these designs in generic drug development.