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Tag: BE study design

Statistical Analysis in BE Studies: How to Calculate Power and Sample Size Correctly
bioequivalence study power analysis sample size calculation BE study design statistical power

Statistical Analysis in BE Studies: How to Calculate Power and Sample Size Correctly

Learn how to correctly calculate power and sample size for bioequivalence studies to meet FDA and EMA requirements. Avoid costly failures with practical guidance on CV%, GMR, RSABE, and regulatory best practices.

December 28 2025

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