Table 4.
Population Pharmacokinetic Parameters for GA2-50 (n = 54) Along With Their Associated Interanimal Variability Upon i.v. Administration to Sprague–Dawley Rats
| Parameter | Estimate | % IAVa |
|---|---|---|
| CL (L/h/kg) | 1.34 (9.3) | 11.3 (69.3) |
| Vc (L/kg) | 8.09 (13.6) | 57.8 (38.3) |
| Vp (L/kg) | 27.9 (10.5) | 38.3 (79.6) |
| Q (L/h/kg) | 7.8 (19.9) | 34.1 (43.4) |
| % Residual error | 10 (Fixed) | NE |
| t1/2 (h) b | 19.2 | 15.1 |
| Vss (L/h/kg) b | 37.3 | 16.3 |
Values in parentheses are % CV.
CL, clearance; Vc, volume of the central compartment; Vp, volume of the peripheral compartment; Q, intercompartmental clearance; Vss, steady state volume of distribution; NE, not estimated.
a
The IAV estimates should be interpreted with caution given the difficulty in fully resolving the IAV from the residual random error with the destructive sampling design.
b
t1/2 and Vss were calculated as secondary parameters from the NONMEM empirical Bayes estimates of the individual animal-specific pharmacokinetic parameters.