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Tag: bioequivalence study

Statistical Analysis in BE Studies: How to Calculate Power and Sample Size Correctly
  • Nov, 20 2025
  • 14 Comments
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 avoid costly failures. Understand key factors like CV%, GMR, and regulatory requirements for FDA and EMA compliance.

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