Instructor: Dr. Thomas Mathew, UMBC Presidential Research Professor
Title: The Statistical Assessment of Bioequivalence and Biosimilarity.
Description:The topic of bioequivalence deals with procedures for testing the equivalence of two drug products: typically, a generic drug and a brand name drug. Biological availability or bioavailability of a drug is the rate and extent to which the active drug ingredient is absorbed into the blood, and becomes available at the site of drug action. Two drug products are bioequivalent if they have similar rate and extent of absorption into the blood. In the workshop, the bioequivalence problem will be introduced using examples, and its historical development will be described. The data for bioequivalence assessment are generated using cross-over designs, and the data are obtained on three variables: Area under the time-concentration curve (AUC), the maximum blood concentration (Cmax) of the active ingredient, and the time to reach the maximum concentration (Tmax). Univariate bioequivalence consists of the separate modeling and analysis of the data on each of these variables. Multivariate bioequivalence consists of the joint modeling and analysis of the data on the three variables. Various statistical criteria used for bioequivalence assessment will be explained, and the statistical methodology for testing the corresponding hypotheses will be addressed. A well known and widely used procedure for testing average bioequivalence (i.e., equivalence of population means) is the two one-sided test or TOST. The emerging area of equivalence testing in the context of biosimilars will be addressed. Some recent developments in the area of equivalence testing will also be mentioned.