. 2018 Feb 9;45(3):443–456. doi: 10.1007/s10928-018-9574-0

Table 4.

Comparison of model predicted and clinically observed pharmacokinetic parameters (Results are for a population representative virtual subject for all studies used for optimization, except Menon et al., which is verification in a virtual population of 100 subjects)

Clinical study	PK parameter	Prediction	Observation	Pred:obs Ratio
Faulkner et al. (IV) [32]	AUC_∞ (ng-h/mL)	303	371	0.82
Faulkner et al. (IV) [32]	t_1/2 (h)	39.9	33.8	1.18
Faulkner et al. (oral) [32]	AUC_∞ (ng-h/mL)	201	238	0.84
	C_max (ng/mL)	5.45	5.9	0.92
	T_max (hr.)	6.09	7.6	0.8
	t_1/2 (h)	39.9	35.7	1.12
	F (%)	66.6	64	1.04
Glesby et al.^a (DDI) [11]	C_max ratio	1.74	1.82	0.96
Glesby et al.^a (DDI) [11]	AUC₂₄ ratio	1.89	1.89	1.0
Menon et al.^b (DDI) [12]	C_max ratio	1.42 (1.39-1.45)	1.26 (1.11-1.44)	1.13
Menon et al.^b (DDI) [12]	AUC_∞ ratio	2.28 (2.19-2.38)	2.57 (2.31-2.86)	0.89

IV intravenous, DDI drug–drug interaction

^aIndinavir/Ritonavir + Amlodipine

^bOmbitasvir/Paritaprevir/Ritonavir + Dasabuvir + Amlodipine