Parallel Study Design

The Getting started example assumes a crossover design where every subject receives both the IV reference and the oral test formulations. This guide demonstrates a parallel design where one group receives IV only and a separate group receives the oral formulations. Since oral subjects have no individual IV data, UIR fitting uses the mean_uir_fallback=true option to apply the mean UIR from the IV group.

Simulated data

Group A (subjects 1–10) receives only the IV bolus. Group B (subjects 11–20) receives three oral formulations but no IV data.

first(pk_df, 8)

8×4 DataFrame

Row	id	formulation	time	conc
	Int64	String	Float64	Float64
1	1	IV	0.0	8.84915
2	1	IV	0.5	7.86636
3	1	IV	1.0	6.99273
4	1	IV	1.5	6.21611
5	1	IV	2.0	5.52575
6	1	IV	2.5	4.91207
7	1	IV	3.0	4.36653
8	1	IV	3.5	3.88159

first(diss_df, 8)

8×3 DataFrame

Row	formulation	time	diss
	String	Float64	Float64
1	FormA	0.0	0.0
2	FormA	0.5	0.0432318
3	FormA	1.0	0.117503
4	FormA	1.5	0.20518
5	FormA	2.0	0.297811
6	FormA	2.5	0.389884
7	FormA	3.0	0.477703
8	FormA	3.5	0.558902

Running the pipeline with `mean_uir_fallback`

The key parameter is mean_uir_fallback=true: oral subjects (who lack IV data) are deconvolved using the population-mean UIR computed from the IV-only group.

result = run_ivivc(
    pk_df,
    diss_df;
    fast_formulation = "IV",
    validation_formulation = "FormB",
    times = collect(range(0.0, 48.0, length = 101)),
    mean_uir_fallback = true,
);

UIR fits

Only the IV-group subjects have individual UIR fits. The mean UIR is applied to the oral-group subjects during deconvolution.

first(result.uir_df, 8)

8×3 DataFrame

Row	id	formulation	uir
	Any	String	PolyExpo…
1	3	IV	PolyExponential{Float64, Float64}([9.87871], [0.199118], 1.0, 1.0)
2	2	IV	PolyExponential{Float64, Float64}([10.0916], [0.183047], 1.0, 1.0)
3	1	IV	PolyExponential{Float64, Float64}([8.84915], [0.235451], 1.0, 1.0)
4	4	IV	PolyExponential{Float64, Float64}([12.5107], [0.198256], 1.0, 1.0)
5	5	IV	PolyExponential{Float64, Float64}([8.84737], [0.204248], 1.0, 1.0)
6	6	IV	PolyExponential{Float64, Float64}([8.72146], [0.230911], 1.0, 1.0)
7	8	IV	PolyExponential{Float64, Float64}([9.39545], [0.203476], 1.0, 1.0)
8	7	IV	PolyExponential{Float64, Float64}([9.70289], [0.192404], 1.0, 1.0)