Abstract
Highly variable (HV) drugs are defined as those for which within-subject variability in bioequivalence (BE) measures is 30 % or greater. Studies designed to show whether a test highly variable drug product (either a generic or reformulated new drug) is bioequivalent to its corresponding reference highly variable drug product may need to enroll large numbers of subjects even when the products have no significant mean differences. To avoid unnecessary human testing, the US Food and Drug Administration (FDA) developed a reference-scaled average bioequivalence (RSABE) approach, whereby the BE acceptance limits are scaled to the variability of the reference product. For an acceptable RSABE study, an HV drug product must meet the scaled BE limit and a geometric mean ratio (GMR) constraint. The approach has been implemented successfully by the FDA, to date supporting approvals of both new generic drug products and reformulated modified-release (MR) new drug products.
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