Statistical Assessment of Bioequivalence and Biosimilarity
2017 January 18

A special lecture on ‘Statistical Assessment of Bioequivalence and Biosimilarity’ was held on the 18th January, 2017 at 11.00 am at the PGIS. The lecture was given by Dr. Thomas Mathew from the Department of Mathematics and Statistics, University of Maryland Baltimore County, Baltimore, Maryland, USA. He received his PhD in statistics from the Indian Statistical Institute, Calcutta, in 1983. His research interests include methodological development and interdisciplinary applications of statistics. He has co- two books, & published over 120 papers. He is also an Associate Editor of several journals, including Journal of the American Statistical Association.

The lecture was on the topic of bioequivalence which deals with procedures for testing the equivalence of two drug products: typically, a generic drug and a brand name drug on the market. Bioequivalence testing consists of showing that the concentration of the active drug ingredient that enters the blood is similar for the two drugs. Area under the time-concentration curve, or the AUC, is usually used for this purpose, and the data are obtained based on cross-over designs. In the talk, the bioequivalence problem will be introduced, its history will be discussed, and examples will be provided. Statistical criteria that are used for bioequivalence testing, especially the criterion of average bioequivalence, will be briefly discussed. The emerging area of equivalence testing in the context of biosimilars (manufactured using microorganisms) will be briefly touched upon. The talk will be mostly non-technical, addressed to a general audience.

Students and academic staff members from many Faculties attended the lecture. The event was coordinated by Professor Pushpa Wijekoon and was organized by the International Research Centre in collaboration with the Postgraduate Institute of Science.