Bioequivalence Calculator
90% Confidence Interval assessment per FDA/EMA guidelines
Regulatory Assessment
Study Parameters
Study Design
Estimated Power
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AUC (Primary Endpoint)
Test
Reference
Cmax (Secondary Endpoint)
Test
Reference
Example Studies
Bioequivalence Result
Enter Study Data
Regulatory Guidelines
FDA/EMA: 90% CI of AUC and Cmax within 80-125%
Sample size: Typically 18-24 subjects for adequate power
Design: Randomized, two-period crossover