Stage 4: analysis (executed output)

Table 14.4.3.2 ANOVA effects

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 14.4.3.2 ANOVA Effects for ln(Cmax) and ln(AUC(0-t))

Bioequivalence set

Study SIMBE01 (synthetic)


	DF	Sum of squares	Mean square	F	Error term	p-value
ln(Cmax): Sequence	1	0.0058	0.0058	0.02	Participant(sequence)	0.8797
ln(Cmax): Participant(sequence)	36	8.9749	0.2493	78.49	Residual	<0.0001
ln(Cmax): Period	1	0.0064	0.0064	2.00	Residual	0.1657
ln(Cmax): Formulation	1	0.0022	0.0022	0.68	Residual	0.4156
ln(Cmax): Residual	36	0.1143	0.0032
ln(AUC(0-t)): Sequence	1	0.0656	0.0656	0.34	Participant(sequence)	0.5651
ln(AUC(0-t)): Participant(sequence)	36	7.0093	0.1947	10.02	Residual	<0.0001
ln(AUC(0-t)): Period	1	0.0040	0.0040	0.21	Residual	0.6526
ln(AUC(0-t)): Formulation	1	0.0290	0.0290	1.49	Residual	0.2295
ln(AUC(0-t)): Residual	36	0.6993	0.0194

Sequence is tested against participant(sequence); the other effects against the residual mean square.

Sequence and participant(sequence) sums of squares are sequential; period and formulation are adjusted for all other terms.

No test for carry-over (ICH M13A).

Synthetic data; not a regulatory deliverable.

Files: t_14_4_3_2.rtf (RTF from formatters::export_as_rtf()), t_14_4_3_2.csv (the displayed cells). Program: study/04_analysis/03_tlf.R.