Department of
presents
Dr. Thomas Mathew
"The Assessment of
Multivariate Bioequivalence"
ABSTRACT
The purpose of bioequivalence testing is to compare the bioavailabilities of two drug products: a brand name drug and a generic drug, for the purpose of establishing the equivalence between the two. The bioavailability of a drug is defined as the rate and extent to which the active ingredient in the drug is absorbed into the blood. The primary data for bioequivalence testing consist of the concentration of the active ingredient in the blood measured at several time points, after administering the drug. The concentration is plotted against time, and three responses are obtained: the area under the blood concentration-time curve, simply referred to as area under the curve or AUC, the maximum concentration that shows up in the blood, and the time to reach the maximum concentration. Univariate bioequivalence consists of the separate modeling and analysis of the data based on the three univariate responses. Multivariate bioequivalence consists of the joint modeling and analysis of the data on the three variables. It is standard practice to use mixed effects models. Very extensive literature is available on the topic of univariate bioequivalence testing; a brief review will be given in my talk. There are three components to the problem: average bioequivalence, subject-by-formulation interaction, and variance bioequivalence. In the univariate case, statistical procedures have been developed to address each of these. The literature in the multivariate case is very limited, dealing only with average bioequivalence. In my talk, I will address all the three components in the context of multivariate bioequivalence testing, and will describe test procedures in each case, along with some data analysis.
Friday,
February, 24, 2006
3:35 - 4:35 pm
206 Cox Hall
Refreshments will be served on the second floor of Dabney Hall (left of Room 222) at 3:00 pm.