Table V.
Power and Consumer Risk Using the FDA Regulatory Recommendation for NTI Drugs
| s WT/s WR | Power at GMR = 0 (μ T − μ R)/σ R = 0 | Consumer risk (μ T − μ R)/σ R = θ | ||||
|---|---|---|---|---|---|---|
| FDA | Exact | ABEL | FDA | Exact | ABEL | |
| 0.5 | 99.15 | 99.28 | 99.45 | 4.18 | 4.02 | 7.60 |
| 1 | 99.95 | 99.96 | 99.97 | 4.06 | 3.55 | 8.86 |
| 2 | 78.01 | 80.08 | 81.66 | 4.41 | 4.98 | 5.86 |
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
Regulatory constant, θ = log(1.111)/0.10
n = 24
With s WT/s WR = 0.5: s WT = 0.05, s WR = 0.10
With s WT/s WR = 1: s WT = 0.10, s WR = 0.10
With s WT/s WR = 2: s WT = 0.10, s WR = 0.05