Individual bioequivalence interim approach urged to allow more data gathering.
This article was originally published in The Tan Sheet
Executive Summary
INDIVIDUAL BIOEQUIVALENCE INTERIM APPROACH PROPOSED to allow an expert panel assembled by FDA to gather more data on the criteria needed to define the term individual bioequivalence, panel member Leslie Benet, PhD, University of California at San Francisco, told an American Association of Pharmaceutical Scientists workshop in Arlington, Va. March 16-18. The expert panel, which met during the AAPS workshop, recommends FDA use an "interim measure" that would allow "intermediate average bioequivalence with mixed scaling, including full replicate design," Benet said.