Table 2.
Pharmacokinetic parameters based on non-linear mixed effects modelling after intravenous administration of 125 U kg−1 turoctocog alfa or N8-GP to severe haemophilia A dogs.
| Turoctocog alfa
|
N8-GP
|
|||
|---|---|---|---|---|
| Estimate | RSE% | Estimate | RSE% | |
| PK | ||||
| V1 (mL kg−1) | 59 | 7 | 63 | 7 |
| CL (mL h−1 kg−1) | 6.5 | 8 | 3.9 | 4 |
| V2 (mL kg−1) | 13 | 17 | 11 | 6 |
| Q (mL h−1 kg−1) | 0.66 | 10 | 0.43 | 29 |
| t½α (h) | 5.4 | – | 9.1 | – |
| t½β (h) | 16 | – | 22 | – |
| PD | ||||
| BASE (min) | 39 | 5 | 39 | 5 |
| EMAX (na) | 0.72 | 2 | 0.72 | 2 |
| EC50 (U mL−1) | 0.0059 | 15 | 0.0059 | 15 |
| Prop error | ||||
| PK (%) | 43 | 6 | 43 | 6 |
| PD (%) | 39 | 7 | 39 | 7 |
V1, volume of central compartment; CL, total clearance; V2, volume of peripheral compartment; Q, inter-compartmental flow; EMAX, the maximum effect (reduction in baseline levels); EC50, the potency of the compound (corresponding to the plasma concentration with half the maximum effect); BASE, WBCT baseline level; t½α, distribution half-life; t½β, terminal half-life; RSE%, relative standard error.