Table 2 Comparison between the proposed method and the conventional CI method in terms of the probability (%) of declaring bioequivalence on the completion of a pivotal trial. Pilot data are simulated based on the scenarios of GMR = 1.0, while pivotal data are simulated under Cases A - E with GMR = 0.8, 0.9, 1.0, 1.1, 1.25, respectively
From: A Bayesian approach to pilot-pivotal trials for bioequivalence assessment
Comparator | \(\eta\) | (w, 1 - w) | Case A | Case B | Case C | Case D | Case E |
|---|---|---|---|---|---|---|---|
GMR = 0.8 | GMR = 0.9 | GMR = 1.0 | GMR = 1.1 | GMR = 1.25 | |||
CI method (\(\alpha\) = 5%) | |||||||
C\(_{\text {max}}\) | 4.94 | 47.47 | 81.64 | 51.84 | 5.18 | ||
AUC | 5.13 | 80.23 | 99.83 | 85.40 | 5.23 | ||
Proposed method | |||||||
C\(_\text {max}\) | 0.75 | (0.5, 0.5) | 56.44 | 94.78 | 99.74 | 95.93 | 54.08 |
AUC | 0.75 | (0.5, 0.5) | 52.65 | 99.14 | 100 | 99.56 | 52.15 |
C\(_\text {max}\) | 0.75 | (0.2, 0.8) | 47.40 | 92.77 | 99.57 | 94.35 | 46.04 |
AUC | 0.75 | (0.2, 0.8) | 43.62 | 98.76 | 100 | 99.23 | 42.39 |
C\(_\text {max}\) | 0.75 | (0.1, 0.9) | 41.39 | 91.02 | 99.47 | 93.29 | 41.68 |
AUC | 0.75 | (0.1, 0.9) | 38.21 | 98.40 | 100 | 98.98 | 37.49 |
C\(_\text {max}\) | 0.75 | (0, 1.0) | 25.39 | 82.93 | 98.47 | 86.51 | 26.42 |
AUC | 0.75 | (0, 1.0) | 25.08 | 97.08 | 100 | 98.29 | 26.09 |