Table 3.
Pharmacodynamic parameters: Fixed- and random-effect variabilities for FOCEI-Priors population estimation approaches
| Parameters | Unit | Definition | Published | FOCEI-Priors | ||
|---|---|---|---|---|---|---|
| Estimate | RSE% [Shrinkage] |
|||||
| Fixed-effect parameters | ||||||
| IC 50 | ng/mL | DEX concentration at 50% maximal effect | 0.0383 | 0.0412 | 4.7% | |
| I max | - | Maximal inhibitory index | 1 (FIX) | 1 | FIX | |
| γ | - | Hill coefficient | 1 (FIX) | 1.19 | 5% | |
| R a | ng/mL | Amplitude | 18.6 | 17.6 | 4.6% | |
| R m1 | ng/mL | Mean baseline/mesor for Study 2 (IM doses) | 93.4 | 93 | 0.5% | |
| R m2 | ng/mL | Mean baseline/mesor for other studies | 47.9 | 47 | 1.7% | |
| T p | h (after 8AM) | Acrophase | 0.933 | 0.992 | 13.8% | |
| k out | h− 1 | Loss rate constant of cortisol | 0.405 | 0.246 | 3.3% | |
| R max_stress | ng/mL | Stress-induced maximal cortisol surge | 44.8 | 24.7 | 5.7% | |
| τ | h | Duration of cortisol surge | 0.34 (FIX) | 0.34 | FIX | |
| Between-subject variability (BSV) | ||||||
| ω 2 Rm | - | BSV in Rm | 0.12 | 14.4% [5.1%] | ||
| Residual unexplained variability | ||||||
| Additive error | 20 | 0.8% [1.1%] | ||||