Table II.
Design | Power at GMR = 1 (μ T − μ R)/σ R = 0 | Consumer risk (μ T − μ R)/σ R = θ | ||||
---|---|---|---|---|---|---|
FDA | Exact | ABEL | FDA | Exact | ABEL | |
TRTR-RTRT | 96.62 | 97.63 | 97.66 | 3.91 | 4.45 | 6.09 |
TRT-RTR | 81.18 | 85.78 | 85.90 | 4.04 | 4.29 | 6.88 |
RRT-RTR-TRR | 88.16 | 89.33 | 90.52 | 4.21 | 4.40 | 5.50 |
GMR geometric mean ratio; FDA the method recommended by FDA; 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
n = 24; s WR = s WT = s W = 0.4