ABSTRACT
Steven Ye Hua, Siyan Xu, Kerry B. Barker, Shan Mei Liao, and Shujie Li
ABSTRACT In this chapter, we present two case studies using Bayesian methods. In the rst case study, a Bayesian approach was taken to assess average bioequivalence and biosimilarity by conducting an interim analysis of a pharmacokinetic similarity trial to determine probability of success. The second case study describes derivation of a margin, which is used to demonstrate similarity of two versions of a biologic drug in a Phase 3 biosimilar clinical trial for the treatment of rheumatoid arthritis disease.
