Scaled Average Bioequivalence for Highly Variable Drugs

• Activity Number: 329
• Type: Topic Contributed
• Date/Time: Tuesday, August 3, 2010 : 10:30 AM to 12:20 PM
• Sponsor: Biopharmaceutical Section
• Author(s): Scott Patterson*+ and Byron Jones and Dieter Hauschke
• Companies: Pfizer Inc. and Pfizer Inc. and University Medical Center Freiburg
• Keywords: bioequivalence ; scaled ; average ; geometric mean ; simulation

Abstract

The two-one sided test procedure (TOST) has been used for average bioequivalence testing since 1992 and is required when marketing new formulations of an approved drug. TOST is known to require comparatively large numbers of subjects to demonstrate bioequivalence for highly variable drugs, defined as those drugs having intra-subject coefficients of variation greater than 30%, but has been shown to protect public health when multiple generic formulations enter the market. Recently, scaled average bioequivalence (SABE) has been proposed as an alternative to TOST. Following a brief summary of SABE design and analysis methods, we will consider the statistical ramifications of the proposed point estimate decision rule and the potential impact of implementation of scaled average bioequivalence in the marketplace using simulation.