Table II.
Power, Type I Error Rates and Sample Size Characteristics for Method C Applied to Parallel Bioequivalence Designs
CV | N 1 | Power | Type I error rate | AvgN | F5 | F50 | F95 |
---|---|---|---|---|---|---|---|
0.1 | 48 | 1.000 | 0.0504 | 48.0 | 48 | 48 | 48 |
0.2 | 48 | 0.908 | 0.0499 | 48.2 | 48 | 48 | 48 |
0.3 | 48 | 0.827 | 0.0479 | 74.4 | 48 | 72 | 122 |
0.4 | 48 | 0.806 | 0.0410 | 148.5 | 48 | 152 | 212 |
0.5 | 48 | 0.790 | 0.0311 | 231.6 | 160 | 228 | 316 |
0.6 | 48 | 0.787 | 0.0298 | 318.5 | 218 | 314 | 434 |
0.7 | 48 | 0.785 | 0.0295 | 412.4 | 282 | 406 | 562 |
0.8 | 48 | 0.784 | 0.0297 | 511.0 | 350 | 504 | 696 |
0.9 | 48 | 0.784 | 0.0297 | 612.2 | 420 | 604 | 836 |
1.0 | 48 | 0.784 | 0.0297 | 714.7 | 490 | 704 | 976 |
0.1 | 120 | 1.000 | 0.0502 | 120.0 | 120 | 120 | 120 |
0.2 | 120 | 0.999 | 0.0502 | 120.0 | 120 | 120 | 120 |
0.3 | 120 | 0.938 | 0.0506 | 120.0 | 120 | 120 | 120 |
0.4 | 120 | 0.830 | 0.0454 | 131.2 | 120 | 120 | 178 |
0.5 | 120 | 0.824 | 0.0478 | 185.8 | 120 | 200 | 278 |
0.6 | 120 | 0.815 | 0.0467 | 280.9 | 120 | 308 | 388 |
0.7 | 120 | 0.804 | 0.0368 | 401.0 | 280 | 410 | 504 |
0.8 | 120 | 0.797 | 0.0303 | 509.9 | 406 | 508 | 624 |
0.9 | 120 | 0.796 | 0.0298 | 611.9 | 488 | 608 | 748 |
1.0 | 120 | 0.795 | 0.0294 | 714.6 | 570 | 710 | 874 |
The evaluation for bioequivalence is based on an assumption of unequal variances. Both test and reference were simulated with the CVs indicated
N 1 sample size at stage 1, AvgN average total sample size, F5 5th percentile of total sample sizes, F50 50th percentile of total sample sizes, F95 95th percentile of total sample sizes