Evaluate Group Sequential Design Sample Sizes for Reference-Scaled Average Bioequivalence Based on Monte Carlo Simulations in Highly Variable Drugs
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 s...
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| Main Authors: | , , , , , , , |
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| Format: | Article |
| Language: | English |
| Published: |
Wiley
2024-01-01
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| Series: | Journal of Probability and Statistics |
| Online Access: | http://dx.doi.org/10.1155/2024/5636591 |
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