Approximate confidence limit for the reference scaled bioequivalence with a parallel design

ABSTRACT

The reference scaled bioequivalence has been proposed with many successful applications for the highly variable products. The statistical properties for the reference scaled bioequivalence have been studied for the commonly used crossover design. However, a crossover design may not be feasible in a real application such as the biosimilar study, instead a parallel design is a more timely and cost-effective choice. In this paper, the approximate upper confidence interval limit for the linearized criteria in the reference scaled bioequivalence from a parallel design is derived. The performance of the approximation is evaluated through the simulation. The simulation results show that this approximation performs well and gives reasonable power and well-controlled type I error.

KEYWORDS:

• Linearized criterion
• parallel design
• reference scaled bioequivalence
• upper limit

Acknowledgments

We thank Dr. Shein-Chung Chow, an associate editor, and two referees for the detailed comments that greatly improved the presentation.