Evaluate Group Sequential Design Sample Sizes for Reference‐Scaled Average Bioequivalence Based on Monte Carlo Simulations in Highly Variable Drugs
FuDong Wen,
Dan Liu,
Wei Tian
et al.
Abstract:The U.S. Food and Drug Administration (FDA) suggests the “Reference‐Scaled Average Bioequivalence” (RSABE) method in the average bioequivalence (ABE) study of highly variable drugs. The classic sample size estimation method for grouping sequential design (GSD) of the RSABE method is a single‐stage sample size multiplied by the inflation factor. This study proposed a new method for calculating the sample size for the GSD of the RSABE: using simulation experiments directly. In this work, our focal point is on a … Show more
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