Evaluate Group Sequential Design Sample Sizes for Reference-Scaled Average Bioequivalence Based on Monte Carlo Simulations in Highly Variable Drugs by FuDong Wen, Dan Liu, Wei Tian, Ce Ji, Yue Su, Miao He, Nan Yang, YuPeng Wang

“…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. …”
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