. 2013 Jul 9;15(4):1012–1024. doi: 10.1208/s12248-013-9505-3

Table V.

Comparison Between Observed and PBPK Model Predicted Parameters

Drug	PK Parameters	Pregnant Women (third trimester)			Non-pregnant Women (PP)			Fold Change (pregnant vs. non-pregnant)
Drug	PK Parameters	Observed^a	Predicted^b	Prediction Fold error^c	Observed^a	Predicted^b	Prediction Fold error^c	Observed^a	Predicted^b	Prediction Fold error^c
Metformin	C _{max_ss} (ng/mL)	1,135	1,068, 1,070	1.0, 1.1	1,611	1,471	1.1	0.71	0.73, 0.73	1.0, 1.0
	t _max (h)	2.0	2.5, 2.6	1.2, 1.3	1.8	2.4	1.4
	AUC_{12h_ss} (ng h/mL)	6,937	6,563, 6,698	1.0, 1.0	9,804	9,463	1.0	0.70	0.69, 0.71	1.0, 1.0
Digoxin	C _max (ng/mL)	0.8	0.84, 0.81	1.1, 1.0	1.1	1.01	1.1	0.90	0.83, 0.80	1.1, 1.1
	t _max (h)	1.6	1.7, 1.6	1.1, 1.0	1.3	1.6	1.2
	AUC_48h (ng h/mL)	7.3	8.0, 8.1	1.1, 1.1	9.3	9.54	1.0	0.81	0.84, 0.85	1.0, 1.0
Midazolam	C _max (ng/mL)	6.4	5.33, 5.11	1.2, 1.3	9.3	9.5	1.1	0.72	0.56, 0.54	1.3, 1.3
	t _max (h)	0.56	0.4, 0.4	1.4, 1.4	0.54	0.4	1.4
	AUC_inf (ng h/mL)	9.5	12.5, 12.2	1.3, 1.3	17.9	22.7	1.1	0.54	0.55, 0.54	1.0, 1.0
Emtricitabine	C _{max_ss} (μg/mL)	1.4	0.94, 0.96	1.5, 1.5	1.4	1.3	1.2	0.97	0.72, 0.74	1.3, 1.3
	t _max (h)	2.0	1.4, 1.5	1.4, 1.3	2.0	1.3	1.4
	AUC_{24h_ss} (μg h/mL)	8.0	8.0, 8.0	1.0, 1.0	9.7	11.2	1.1	0.82	0.71, 0.71	1.2, 1.2

^aObserved data was obtained from values reported in the literatures

^bPredicted PK parameters are presented as “model 1, model 2”

^cFold error (FE) was calculated as FE = 10^{|log(Predicted/Observed)|}. Calculated FE are presented as “model 1, model 2”