Table 4.
Integrated PK–PD–efficacy model parameter estimate for patients with advanced solid tumors (phase 1 studies)
| Parameter | Unit | Estimate | RSE% | Variability% | Shrinkage% |
|---|---|---|---|---|---|
| Kg | 1/week | 0.0097 | 20.7 | – | – |
| Kmax | 1/week | 0.0142 | 43.9 | – | – |
| KI50 | %pAKT inhibition | 58.0 | 34.3 | – | – |
| γ2 | – | 6.52 | 101.4 | – | – |
| Proportional error | – | 0.141 | 2.3 | – | – |
| IIV Kg | Variance | 0.668 | 34.9 | 81.7 | 37.9 |
| IIV Kmax | Variance | 0.377 | 44.6 | 61.4 | 55.8 |
| IIV KI50 | Variance | 0.0225 (fix) | – | – | – |
| IIV γ2 | Variance | 0.0225 (fix) | – | – | – |
IIV, interindividual variability; Kg, net tumor growth rate constant; Kmax, maximum value of Ks; KI50, I where Ks is 50% of Kmax; RSE, relative standard error; γ2, sigmoidicity factor