Table 3 Probability of incorrectly declaring bioequivalence (%) for pivotal trials analyzed using the proposed method. Pilot data are simulated based on scenario 5 wherein GMR = 1.0, while pivotal data are simulated under six additional cases that feature GMR =0.5, 0.7, 0.8, 1.25, 1.43, 2.0, respectively
From: A Bayesian approach to pilot-pivotal trials for bioequivalence assessment
GMR | \(\eta\) | (w, 1 - w) | ||||
|---|---|---|---|---|---|---|
(0, 1.0) | (0.1, 0.9) | (0.2, 0.8) | (0.5, 0.5) | |||
C\(_\text {max}\) | 0.5 | 0.5 | 0 | 0 | 0 | 0 |
0.5 | 0.6 | 0 | 0 | 0 | 0 | |
0.5 | 0.7 | 0 | 0 | 0 | 0 | |
0.5 | 0.8 | 0 | 0 | 0 | 0 | |
0.5 | 0.9 | 0 | 0 | 0 | 0 | |
0.7 | 0.5 | 3.61 | 9.11 | 11.68 | 17.19 | |
0.7 | 0.6 | 2.02 | 5.85 | 7.88 | 11.66 | |
0.7 | 0.7 | 1.15 | 3.44 | 4.85 | 7.45 | |
0.7 | 0.8 | 0.51 | 1.63 | 2.53 | 4.51 | |
0.7 | 0.9 | 0.12 | 0.61 | 0.86 | 1.58 | |
0.8 | 0.5 | 49.44 | 66.81 | 70.90 | 77.22 | |
0.8 | 0.6 | 40.09 | 57.64 | 62.86 | 70.05 | |
0.8 | 0.7 | 30.37 | 47.13 | 53.08 | 61.96 | |
0.8 | 0.8 | 20.45 | 35.42 | 41.11 | 49.87 | |
0.8 | 0.9 | 11.21 | 20.98 | 25.15 | 32.37 | |
1.25 | 0.5 | 50.62 | 64.55 | 68.97 | 75.65 | |
1.25 | 0.6 | 41.09 | 56.31 | 61.07 | 68.04 | |
1.25 | 0.7 | 31.17 | 47.14 | 51.68 | 59.47 | |
1.25 | 0.8 | 21.69 | 35.73 | 40.47 | 48.27 | |
1.25 | 0.9 | 11.70 | 22.81 | 26.40 | 32.76 | |
1.43 | 0.5 | 3.29 | 7.9 | 10.35 | 15.39 | |
1.43 | 0.6 | 1.83 | 4.87 | 6.49 | 10.30 | |
1.43 | 0.7 | 1.01 | 2.77 | 3.76 | 6.33 | |
1.43 | 0.8 | 0.41 | 1.46 | 1.94 | 3.40 | |
1.43 | 0.9 | 0.09 | 0.56 | 0.74 | 1.35 | |
2.0 | 0.5 | 0 | 0 | 0 | 0 | |
2.0 | 0.6 | 0 | 0 | 0 | 0 | |
2.0 | 0.7 | 0 | 0 | 0 | 0 | |
2.0 | 0.8 | 0 | 0 | 0 | 0 | |
2.0 | 0.9 | 0 | 0 | 0 | 0 | |
AUC | 0.5 | 0.5 | 0 | 0 | 0 | 0 |
0.5 | 0.6 | 0 | 0 | 0 | 0 | |
0.5 | 0.7 | 0 | 0 | 0 | 0 | |
0.5 | 0.8 | 0 | 0 | 0 | 0 | |
0.5 | 0.9 | 0 | 0 | 0 | 0 | |
0.7 | 0.5 | 0.21 | 0.63 | 0.93 | 2.16 | |
0.7 | 0.6 | 0.09 | 0.37 | 0.55 | 1.10 | |
0.7 | 0.7 | 0.03 | 0.17 | 0.29 | 0.60 | |
0.7 | 0.8 | 0.03 | 0.06 | 0.12 | 0.27 | |
0.7 | 0.9 | 0 | 0.01 | 0.02 | 0.06 | |
0.8 | 0.5 | 49.83 | 62.58 | 65.77 | 72.77 | |
0.8 | 0.6 | 40.37 | 53.05 | 58.08 | 66.35 | |
0.8 | 0.7 | 30.01 | 43.48 | 49.04 | 57.85 | |
0.8 | 0.8 | 20.20 | 32.10 | 37.68 | 46.60 | |
0.8 | 0.9 | 10.58 | 19.49 | 23.76 | 31.35 | |
1.25 | 0.5 | 51.26 | 59.56 | 63.39 | 71.49 | |
1.25 | 0.6 | 41.06 | 51.05 | 55.58 | 64.56 | |
1.25 | 0.7 | 30.69 | 42.42 | 46.96 | 56.49 | |
1.25 | 0.8 | 21.43 | 32.49 | 37.64 | 47.38 | |
1.25 | 0.9 | 11.16 | 20.74 | 24.27 | 33.89 | |
1.43 | 0.5 | 0.16 | 0.41 | 0.73 | 1.55 | |
1.43 | 0.6 | 0.06 | 0.19 | 0.35 | 0.89 | |
1.43 | 0.7 | 0.03 | 0.10 | 0.17 | 0.41 | |
1.43 | 0.8 | 0.01 | 0.03 | 0.07 | 0.18 | |
1.43 | 0.9 | 0 | 0.02 | 0.02 | 0.06 | |
2.0 | 0.5 | 0 | 0 | 0 | 0 | |
2.0 | 0.6 | 0 | 0 | 0 | 0 | |
2.0 | 0.7 | 0 | 0 | 0 | 0 | |
2.0 | 0.8 | 0 | 0 | 0 | 0 | |
2.0 | 0.9 | 0 | 0 | 0 | 0 | |