Table II.
Pharmacokinetic Parameter Estimates, Standard Errors, and Bootstrap Results for Final Model
| Parameter | Estimate | %RSE | Bootstrap estimate (standard error) | Bootstrap estimate (95% CI) |
|---|---|---|---|---|
| CL/F (L/h)—high clearance | 11.6 | 36.0 | 12.8 (4.63) | (6.50–24.28) |
| CL/F (L/h)—low clearance | 3.34 | 19.1 | 3.31 (0.637) | (2.42–4.67) |
| V2/F (L) | 37.4 | 10.2 | 37.5 (3.83) | (30.4–46) |
| V3/F (L) | 1 | – | – | – |
| V4/F (L) | 120 | 12.4 | 123 (15.92) | (94.6–156) |
| Q/F (L/h) | 21.9 | 14.4 | 22.3 (3.28) | (16.1–29.0) |
| Ka (h−1) | 1.26 | 7.21 | 1.27 (0.102) | (1.10–1.51) |
| Moderate renal impairment on Ka | −0.744 | 11.6 | −0.722 (0.174) | (−0.874–(−0.391)) |
| Fmetest (L−1) | 0.201 | 16.8 | 0.201 (0.032) | (0.137–0.267) |
| CLM/F (L/h) | 2.43 | 15.1 | 2.41 (0.343) | (1.73–3.14) |
| Probability | 0.251 | 61.0 | 0.278 (0.131) | (0.038–0.534) |
| IIV (variances and %CV) | ||||
| IIV-CL/F | 0.200 (44.7) | 43.4 | 0.163 (0.073) | (0.046–0.318) |
| IIV-V2/F | 0.443 (66.6) | 29.1 | 0.434 (0.142) | (0.207–0.739) |
| IIV-V4/F | 0.426 (65.3) | 33.3 | 0.416 (0.144) | (0.165–0.736) |
| IIV-Q/F | 0.457 (67.6) | 31.9 | 0.432 (0.145) | (0.160–0.731) |
| IIV-Ka | 0.280 (52.9) | 45.7 | 0.263 (0.127) | (0.433–0.557) |
| IIV-Fmetest | 0.196 (44.3) | 22.5 | 0.189 (0.044) | (0.109–0.282) |
| RV (log error) | ||||
| Telapristone (nmol/L) | 0.378 | 15.8 | 0.378 (0.061) | (0.267–0.516) |
| CDB-4453 (nmol/L) | 0.109 | 18.6 | 0.109 (0.020) | (0.073–0.156) |