Celerion

Scientific Input
Study Design
Consulting

Need

• The client successfully performed a bioequivalence study for European submission on a nonsteroidal androgen compound using a panel of 32 subjects
• Since the formulation demonstrated bioequivalence to the European reference product, the client indicated interest in conducting a similar study against the United States reference product for approval by the FDA

Approach

• Thorough review of data by protocol scientist, experienced with FDA regulations for the design and conduct of bioequivalence studies for submission to the U.S.
• Partnering with Celerion’s statistician, the protocol scientist advised the client that based on the ratio and variability derived from the previous study, a panel of 20 subjects rather than 32 would be sufficient to conclude bioequivalence with adequate statistical power

Benefits

• Designed a study that was less expensive than originally planned – the client saved approximately 30% on each of the two studies required for FDA submission
• Optimized sampling schedule maximizes potential to characterize the formulation in-vivo performance
• Thorough statistical assessment can optimize chances of concluding bioequivalence whilst minimizing cost to the client by avoiding unnecessary trial execution costs