Table I.
Power and Consumer Risk for Parallel Design Bioequivalence Studies Evaluated with Four RSABE Algorithms
| Subject n | Power at GMR = 1 (μ T − μ R)/σ R = 0 | Consumer risk (μ T − μ R)/σ R = θ | ||||||
|---|---|---|---|---|---|---|---|---|
| FDA | C.I. | Exact | ABEL | FDA | C.I. | Exact | ABEL | |
| 10 | 14.37 | 12.13 | 24.36 | 21.16 | 2.23 | 1.82 | 4.17 | 3.59 |
| 20 | 65.08 | 61.74 | 69.74 | 70.24 | 3.98 | 3.29 | 4.86 | 5.14 |
| 30 | 87.72 | 86.04 | 89.35 | 90.12 | 4.32 | 3.64 | 4.93 | 5.47 |
GMR geometric mean ratio; FDA the method recommended by FDA; C.I. confidence interval approach using the noncentral t distribution, a variant of the Exact method; Exact an RSABE test based using the noncentral t distribution and the TOST approach; ABEL average bioequivalence with expanding limits, the approach recommended by EMA