TABLE 2

Comparison of predicted and observed values for PK parameters for ranitidine

Simulation conditions are listed by rank order according to Σδ_all. δ is the absolute difference between one and the ratio of the predicted value of the parameter over the observed value, as defined by eq. 6 in the Materials and Methods section. This table has been abbreviated to contain only the top-five simulations for each dose/RI combination. Supplemental Table 40 provides values for each simulation including actual parameter estimates as well as δ values.

	Dose	δ				Σδ_all	Σδ_R
		AUC	CL	CL_R	A_e	Σδ_all	Σδ_R
	mg
Healthy
Sim-healthy volunteers	50	0.34	0.235	0.400	0.160	1.14	0.560
Sim-healthy volunteers	25	0.53	0.331	0.487	0.179	1.53	0.666
Moderate RI
Sim GFR 30–60	50	0.083	0.090	0.360	0.256	0.789	0.616
OAT3 10% OAT3 R4	50	0.083	0.075	0.060	0.128	0.346	0.188
OAT3 10%	50	0.067	0.060	0.090	0.140	0.357	0.230
OAT3 R4	50	0.044	0.045	0.120	0.156	0.365	0.276
OCT2 R2	50	0.139	0.120	0.066	0.076	0.401	0.142
OCT2 20%	50	0.206	0.170	0.167	0.020	0.563	0.187
Severe RI
Sim GFR less than 30	50	0.423	0.692	3.95	2.27	7.33	6.22
OCT2 20% OAT3 10% OCT2 R2 OAT3 R4	50	0.019	0.037	0.069	0.129	0.254	0.198
OCT2 20% OAT3 10% OCT2 R2	50	0.006	0.019	0.059	0.254	0.338	0.313
OCT2 20% OCT2 R2 OAT3 R4	50	0.035	0.019	0.221	0.396	0.671	0.617
OCT2 20% OAT3 10% OAT3 R4	50	0.058	0.037	0.377	0.527	1.00	0.904
OCT2 20% OAT3 10%	50	0.079	0.065	0.500	0.621	1.27	1.12
Sim GFR less than 30	25	0.396	0.670	20.3	11.5	32.9	31.8
OCT2 20% OAT3 10% OCT2 R2 OAT3 R4	25	0.065	0.055	2.98	3.34	6.44	6.32
OCT2 20% OAT3 10% OCT2 R2	25	0.039	0.028	3.52	3.82	7.41	7.34
OCT2 20% OCT2 R2 OAT3 R4	25	0.009	0.000	4.19	4.37	8.57	8.56
OCT2 20% OAT3 10% OCT2 R2 OAT3 R4 OATP1B3 R1	25	0.452	0.308	2.98	4.85	8.59	7.83
OCT2 20% OAT3 10% OCT2 R2 OATP1B3 R1	25	0.413	0.289	3.52	5.46	9.69	8.98