Bioequivalence Study¶

Complete bioequivalence study with 2x2 crossover design and TOST analysis.

Design¶

Type: 2x2 crossover bioequivalence
Treatments: Reference vs Test formulation
N: 24 subjects (12 per sequence)
Washout: 7 days
BE limits: 80.00% - 125.00%
Parameters: Cmax, AUC0-inf

Regulatory Guidance¶

Following FDA guidance for BE studies: - 90% CI for GMR must be within [0.80, 1.25] - Log-transformed data - TOST (Two One-Sided Tests) procedure

Features Demonstrated¶

BE study design
NCA parameter calculation
90% CI for geometric mean ratio
BE assessment per FDA guidance

Files¶

File	Description
python.py	Python implementation
julia.jl	Julia implementation
cli.json	CLI specification

Expected Output¶

Bioequivalence Study
====================
Design: 2x2 crossover
N: 24 subjects
BE limits: [0.80, 1.25]

Results:
--------
Parameter   GMR      90% CI           BE?
Cmax        0.9845   [0.8912, 1.0875] Yes
AUC0-inf    1.0123   [0.9456, 1.0834] Yes

Conclusion: Bioequivalence demonstrated