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. 2011 Jul 28;68(1):39–53. doi: 10.1007/s00228-011-1095-3

Table 3.

Development of population PK model for garenoxacin

Model no. Model construction a CV ω2CL/F CV ω2Vd/F OBJ (p value)
End of phase II stage (interim analysis)b
  1 Base model 19.4% 18.3% 356.754
  2 CL/F =  θ1 + θ2 × (CLCR − 85) 20.6% 21.0% 271.509 (p  < 0.001)
End of phase III stage (final analysis)c
  1 Base model 37.4% 37.0% 1475.267
  2 CL/F =  θ1 +  θ2 × (CLCR − 85) 19.5% 32.4% 1403.379 (p < 0.001)
V/F =  θ3
  3 CL/F =  θ1 +  θ2 × (CLCR − 85) 20.6% 16.4% 1309.516 (p < 0.001)
V/F =  θ3 × (WT/55) θ4
  4 CL/F =  θ1 +  θ2 × (CLCR − 85) 20.6% 16.4% 1298.040 (p < 0.001)
V/F =  θ3 × (WT/55) θ4 +  θ5 × GEN
  5 (final model) CL/F =  θ1 +  θ2 × (CLCR − 85) +  θ3 × (WT − 55) 20.1% 15.8% 1292.110 (p  = 0.015)
V/F =  θ4 × (WT/55) θ5 +  θ6 × GEN

CV, Coefficient of variance; OBJ, objective function value

aCL/F, Total body clearance; V/F, distribution volume/F; GEN, gender (1: male; 0: female); θ, population mean parameters

bFirst-order method (NONMEM version V, level 1.0)

cFirst-order conditional estimation method with interaction (NONMEM version VI, level 2.0)