Stage 4: analysis (executed output)

Table 14.4.3.1 Bioequivalence result

Executed: rtables 0.6.17 / tern 0.9.13

Synthetic data only: simulated for this worked example; not real trial data and not a regulatory deliverable.

Table 14.4.3.1 Bioequivalence Analysis: Ratio of Geometric Means (Test/Reference) and 90% CI

Bioequivalence set

Study SIMBE01 (synthetic)


	n	Adjusted geometric mean, Test	Adjusted geometric mean, Reference	Ratio T/R (%)	90% CI (%)	Within-participant CV%	Within 80.00 to 125.00%
Cmax (ng/mL)	38	103.3	102.2	101.07	98.89, 103.30	5.6	Yes
AUC(0-t) (h*ng/mL)	38	1204.9	1158.7	103.99	98.52, 109.75	14.0	Yes
AUC(0-inf) (h*ng/mL), supportive	37	1243.3	1188.4	104.62	98.63, 110.97	15.1	Yes

General linear model on ln(parameter): sequence, participant(sequence), period, formulation (fixed effects; ICH M13A).

Adjusted geometric mean = exp(least-squares mean). Ratio and 90% CI back-transformed from the T - R difference; decision on unrounded limits.

Within-participant CV% = 100*sqrt(exp(MSE) - 1).

AUC(0-inf): participants whose AUC(0-inf) passes the SAP parameter rules (at most 20% extrapolated, adjusted R-squared at least 0.90) in both periods.

Synthetic data; not a regulatory deliverable.

Files: t_14_4_3_1.rtf (RTF from formatters::export_as_rtf()), t_14_4_3_1.csv (the displayed cells). Program: study/04_analysis/03_tlf.R.