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. 2014 Feb 14;16(3):373–378. doi: 10.1208/s12248-014-9571-1

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