TITLE: Robust Methods for Assessment of Average and Scaled Average Bioequivalence
SPEAKERS: Divan Burger, University of Pretoria, South Africa
The tutorial presents robust methods for the assessment of both average and scaled average bioequivalence, based on data from conventional cross-over studies and replicate design cross-over studies. Initially, in an empirical study of a large number of average bioequivalence studies, the results of the classic and robust Bayesian analyses are compared, and the need for robust analyses is discussed. Thereafter, the classic and Bayesian robust methods are applied to a group of replicate design bioequivalence studies, and diagnostic plots and outlier diagnostics for such studies are presented. Robust analysis of replicate design bioequivalence data affects not only the estimation of the location parameters of the test and reference formulations but also the within-reference scaling factor; a proposal is made for the appropriate handling of this matter. The proposed Bayesian robust methodology is flexible with regard to study design (conventional cross-over, replicate design cross-over, parallel design) and with regard to the handling of outliers and skewness in the data.
Dr Divan A. Burger obtained BCom (Actuarial Science), BCom (Hons) (Mathematical Statistics) and MCom (Mathematical Statistics) degrees at the University of the Free State (UFS) in 2006, 2007 and 2009. He completed his PhD studies (2013 to 2014) under the supervision of Profs Robert Schall and Abrie van der Merwe at UFS. He previously worked at Quintiles Biostatistics in Bloemfontein (2007 to 2016) as a senior biostatistician, where he specialized in the planning, statistical analysis and reporting of clinical trial data. He was a postdoctoral research fellow at the Department of Mathematical Statistics and Actuarial Science at the University of the Free State (2015 to 2016), where his primary research areas include Bayesian mixed-effects nonlinear regression analysis. Dr Burger is currently employed at the Department of Statistics of the University of Pretoria as a senior lecturer in biostatistics and biometrics. He has published extensively in the Journal of Biopharmaceutical Statistics, Statistics in Medicine, Pharmaceutical Statistics and The Lancet.