Bayesian approach to average bioequivalence using Bayes' factor.
In recent years, bioavailability studies for assessment of bioequivalence between two or more drug formulations have become very popular in drug development. However the current practice for the assessment of bioequivalence suffers from certain serious drawbacks. For example, sometimes these tests fail to control the consumer's risk. In this article a new methodology based on the application of Bayes' factor for solving the average bioequivalence problem is proposed. We compare our approach with the existing methods by using real data sets from the Food and Drug Administration (FDA). Results are further explored using simulation studies.
Department of Mathematics and Statistics, Oakland University, Rochester, Michigan 48309-4485, USA. pghosh@oakland.edu
Pulak
P
Ghosh
Ravindra
R
Khattree
D001499:Bayes Theorem; D006801:Humans; D015233:Models, Statistical; D013810:Therapeutic Equivalency; D014481:United States; D014486:United States Food and Drug Administration