Bioequivalence Study Use Case

Complete workflow for a 2x2 crossover bioequivalence (BE) study comparing a test formulation against a reference formulation.

Study Design

Parameter	Value
Design	2-period, 2-sequence crossover
Subjects per sequence	12 (24 total)
Washout	7 days
Sampling	0, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24 h
BE criteria	90% CI for AUC and Cmax within 80-125%

Formulations

• Reference (R): Approved product, Ka = 1.5 /h
• Test (T): Generic formulation, Ka = 1.4 /h (slightly slower absorption)

Workflow Steps

Step	Script	Description
1	run.jl	Complete BE simulation and analysis

Quick Run

# Run complete BE workflow
julia --project=packages/core docs/examples/use_cases/bioequivalence_study/run.jl

# Validate outputs
julia --project=packages/core docs/examples/use_cases/bioequivalence_study/validate.jl

Expected Results

Geometric Mean Ratios (T/R)

Metric	Point Estimate	90% CI
Cmax	0.95	0.88-1.02
AUC_0_t	1.00	0.95-1.05

BE Conclusion

• Both Cmax and AUC 90% CIs within 80-125%
• Bioequivalence demonstrated

Model Parameters

Parameter	Reference	Test	IIV (CV%)
Ka	1.5 /h	1.4 /h	30
CL	10 L/h	10 L/h	25
V	100 L	100 L	20

See Also

• Trial Examples
• NCA Examples