Table 4.
Precision of Slope Estimate under Various Simulation Designs; Parametric Simulation
| Number Subjects per | False | Median and 90% | Median CI |
|---|---|---|---|
| Moxifloxacin Dose Arm | Negative Rate with | CI of Slope, | Width of Slope, |
| 800 mg/400 mg/200 mg/0 mg | 95% Binomial CI | ms/mg/L | ms/mg/L |
| 0/24/0/24 | 3.5% (0.953, 6.05) | 5.82 (3.75, 7.54) | 3.10 |
| 0/12/0/12 | 4.5% (1.63, 7.37) | 5.71 (3.06, 8.59) | 4.43 |
| 0/6/0/6 | 7% (3.46, 10.5) | 5.53 (1.91, 10.4) | 6.28 |
| 0/6/6/6 | 7.5% (3.85, 11.2) | 5.41 (1.87, 8.61) | 5.98 |
| 6/6/0/6a | 10% (5.84, 14.2) | 5.44 (3.01, 7.91) | 3.20 |
| 6/0/6/6 | 8% (4.24, 11.8) | 5.64 (3.01, 8.00) | 3.13 |
Simulations based on 200 replicates of the PK/PD model.
a
Dose allocation in the proposed study design.