Comparison of Different Methods for Decision-Making in Bioequivalence Assessment

Abstract

If the regulatory requirements are symmetrical, the use of symmetrical confidence intervals as a decision rule for bioequivalence assessment leads, as shown by simulations, to better level properties and an inferior power compared to a rule based on shortest confidence intervals. A choice between these two approaches will have to depend on a loss function. For asymmetric regulatory requirements, symmetrical confidence intervals should not be used; however, a decision can still be based on posterior probabilities, pr (theta epsilon [r1, r2]/x), or shortest confidence intervals. For purposes of inference, presentation and interpretation of results, we think that the use of symmetrical confidence intervals alone can be misleading and we therefore recommend that the posterior probabilities and densities, or at least the shortest confidence intervals, be given.

25 years of Bayesian methods in the pharmaceutical industry: a personal, statistical bummel

“…Rodda and Davis [9] from Merck, Sharp and Dohme, Selwyn and Hall from Ciba-Geigy in the US [10,11] and Mandallaz and Mau from Ciba-Geigy in Switzerland [12], whose work was to give statistical credence to ideas developed by Hugo Flu¨hler and collegues [13]. My own involvement began after David Mandallaz and Jochen Mau had left Ciba-Geigy at the end of 1980 and led initially to an expository article on the approach [14].…”

Application of Information Theory to Bio-Equivalence Problem

“…Bayesian methods were used by Rodda and Davis [19], Mandallaz and Mau [20], and Grieve [21]. Nonparametric methods were used by Hauschke et al (1990).…”

Bioequivalence; Its History, Practice, and Future

“…Several approaches to data analysis and statistical treatment of data were considered by FDA. The major methods included the power approach (reformation of bioequivalence hypotheses) (4,5), the 75/75 rule, the confidence interval approach (6), and the Bayesian approach (7,8).…”