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See Latest ArticlesEvaluation of Bioequivalence for Highly Variable Drugs with Scaled Average Bioequivalence
Clinical Pharmacokinetics, 10/14/09
Tothfalusi L et al. – Pragmatic considerations lead to modifications of the theoretical concept of SABE. Several modifications are proposed, including reference scaling, restriction on the estimated geometric mean ratios and possibly limiting SABE to only secondary bioequivalence metrics such as the maximum concentration. Each proposal has its own merit but is also a source of new controversy. Overall, the statistical evaluation of SABE is more complex than that of ABE, which means higher regulatory burden.
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