Bioequivalence studies based on rate of exposure, not Cmax, under FDA consideration.
This article was originally published in The Tan Sheet
Executive Summary
RATE OF EXPOSURE MEASUREMENTS COULD REPLACE Cmax BIOEQUIVALENCE studies, FDA Division of Pharmaceutical Evaluation II Director Mei-Ling Chen, PhD, told FDA's Advisory Committee for Pharmaceutical Science June 23. "Instead of rate and extent of absorption" for determining bioequivalence, "you may characterize the drug's profile in terms of rate of exposure, which may be composed of three measures: total exposure, peak exposure and early exposure," Chen said.
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