JSM 2005 - Toronto

Abstract #303861

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Legend: = Applied Session, = Theme Session, = Presenter
Activity Number: 100
Type: Contributed
Date/Time: Monday, August 8, 2005 : 8:30 AM to 10:20 AM
Sponsor: Biopharmaceutical Section
Abstract - #303861
Title: A Censored Data Solution for Crossover Studies
Author(s): David Burt*+
Companies: Abbott Laboratories
Address: 801 N Rogers Road, Gurnee, IL, 60031, United States
Keywords: Cross-Over Designs ; Censoring ; LLOQ ; Order Statistics ; Emperical BLUE ; Bioequivalence
Abstract:

In the analysis of bioassays, values below the Lower Limit of Quantification (LLOQ) commonly are observed. There are numerous methods available in the literature for estimating and testing censored data for the one- and two-sample (independent groups) problems, but their extension to the analysis of crossover data is not obvious. Furthermore, many of the commonly used methods, such as those based on maximum likelihood estimation, result in bias estimates and tests. The crossover setup is common when assessing the bioequivalence of two pharmaceutical compounds and biased results are highly undesirable. We provide a method for analyzing crossover data based on the joint distribution of standard order statistics. In the special case of compound symmetry where the within subject correlation coefficient is known, this methodology yields the Best Linear Unbiased Estimates (BLUE) of location and scale. In the more general case, empirical BLUE estimates can be computed. This methodology is demonstrated in an analysis of the maximum plasma concentration (Cmax), where LLOQ censoring is present. The performance of our methodology is assessed via a simulation study.

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Revised March 2005