Table 2.

Parameter estimates for the final BAY 94-9027 population pharmacokinetic model using chromogenic or one-stage assay data

Parameter	Parameter estimate	Parameter SEa (% CV)	95% CI
Chromogenic assay
CL (dL/h)	1.09	2.19	1.04–1.14
Effect of LBW on CLb	0.707	7.93	0.597–0.817
Effect of VWF on CLb	− 0.604	10.2	− 0.725 to − 0.483
Vc (dL)	26.2	1.18	25.6–26.8
Effect of LBW on Vcc	0.887	2.78	0.839–0.935
BSV CL (% CV)	24.0	16.4	19.7–27.8
BSV Vc (% CV)	12.8	17.5	10.4–14.9
Correlation (BSV CL, BSV Vc) (%)	0.449	19.2	0.28–0.618
Additive RUV (variance)	1.78	19.2	1.11–2.45
Proportional RUV	0.175d	5.66	0.156–0.194
One-stage assay
CL (dL/h)	1.02	3.15	0.95‒1.07
Effect of LBW on CLe	0.858	25.6	0.43‒1.29
Effect of VWF on CLe	− 0.583	11.1	− 0.71 to − 0.46
Vc (dL)	24.2	1.67	23.4‒25.0
Effect of LBW on Vcf	0.683	15.2	0.48‒0.89
BSV CL (% CV)	24.0	18.1	19.3–27.9
BSV Vc (% CV)	14.6	15.6	12.2–16.7
Correlation (BSV CL, BSV Vc) (%)	0.485	17.1	0.323‒0.647
Additive RUV (variance)	1.44	13.2	1.07‒1.81
Proportional RUV	0.201g	5.47	0.18‒0.22

BSV between-subject variability, CL clearance, CV coefficient of variance, LBW lean body weight, RUV residual unexplained variability, SE standard error, V_c central volume of distribution, VWF von Willebrand factor

^aEstimate of SE represents SE of respective variance/covariance estimate, not of the derived % CV and correlation estimate

^bCL = 1.09 × (LBW/49.1)^0.707 × (VWF/110)^−0.604

^cV_c = 26.2 × (LBW/49.1)^0.887

^dCorresponds to CV of 41.8%, under the assumption that CV = $\sqrt{{\sigma }^2}$

^eCL = 1.02 × (LBW/49.1)^0.858 × (VWF/110)^−0.583

^fV_c = 24.2 × (LBW/49.1)^0.683

^gCorresponds to CV of 44.8%, under the assumption that CV = $\sqrt{{\sigma }^2}$