Some Methodological and Computational Aspects of Bioequivalence

• Activity Number: 264
• Type: Invited
• Date/Time: Wednesday, August 14, 2002 : 8:30 AM to 10:20 AM
• Sponsor: International Indian Statisticial Assoc, Reps. For Young Statisticians
• Author(s): Pulak Ghosh*+
• Affiliation(s): Oakland University
• Keywords: Bioequivalence ; FDA Guidelines

Abstract

Individual Bioequivalence of various competing drugs such as generics is an important issue for the pharmaceutical industry as well as for the regulatory agencies such as FDA, who must critically examine the data submitted by the pharmaceutical company as well as analyze the data before approving the new competing drug. The FDA recommends guidelines for such studies as well as analyses in its documents. Often such tests are based on approximate methods and often such approximation can be very crude. This talk deals with providing certain better approaches for carrying out such studies resulting in better and more definite inference. The approaches used are based on Bayesian testing as well as exact tests based on generalized p values. These alternative approaches do require more intensive computational schemes. However, implementation of these approaches is not only feasible but also preferred, due to the virtue of the importance of establishing credibility as definitively as possible.