Statistics and Risk Management Seminar - 21/03/2013 - 11:00 a.m. - 12:00 a.m.

Thursday, 21 March 2013, 11:00 a.m. - 12:00 a.m.

Lecturer: Prof. Thomas Mathew, University of Maryland, Baltimore County

Title: "Bioequivalence Testing: An Introduction".

Local: Sala de Seminários, Edifício VII
Faculdade de Ciências e Tecnologia, Quinta da Torre, Caparica

Abstract:The topic of bioequivalence 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.  In this talk, I will provide background information  on the bioequivalence problem and its history. The data to be used for bioequivalence testing, and the experimental designs to be used will be explained, and the statistical criteria to be used  will be introduced. In addition, equivalence testing relating to medical device trials will be outlined. Finally, the emerging area of equivalence testing in the context of biosimilars will be briefly touched upon.