Table 3.
Population Bioequivalence Statistics for Single Actuation Content (mcg): 500/50 mcg Strength
| Flow rate (L/min) | Active | Life stage | GM (T) | GM (R) | SD (T) | SD (R) | Linearized criteria |
|
|---|---|---|---|---|---|---|---|---|
| Point estimate | 95% Upper confidence bound | |||||||
| 30 | FP | BoL | 458.99 | 104.24 | 18.06 | 162.57 | –2.0700R | –0.7543 |
| EoL | 470.36 | 481.88 | 19.97 | 55.44 | –0.0567R | –0.0421 | ||
| MoL | 452.55 | 445.30 | 20.27 | 76.15 | –0.1388R | –0.1043 | ||
| Sal | BoL | 46.20 | 10.40 | 1.47 | 16.02 | –2.0144R | –0.7032 | |
| EoL | 47.38 | 47.41 | 1.72 | 5.38 | –0.0564R | –0.0423 | ||
| MoL | 45.55 | 43.75 | 1.68 | 7.42 | –0.1337R | –0.1000 | ||
| 60 | FP | BoL | 474.46 | 445.78 | 20.66 | 16.31 | –0.0166 | –0.0147 |
| EoL | 478.71 | 497.77 | 19.08 | 12.20 | –0.0184 | –0.0173 | ||
| MoL | 468.53 | 479.82 | 22.19 | 15.37 | –0.0192 | –0.0181 | ||
| Sal | BoL | 47.37 | 44.04 | 1.80 | 1.67 | –0.0158 | –0.0138 | |
| EoL | 48.16 | 48.92 | 1.96 | 1.22 | –0.0197 | –0.0189 | ||
| MoL | 46.65 | 47.13 | 1.90 | 1.48 | –0.0202 | –0.0194 | ||
| 90 | FP | BoL | 481.70 | 451.22 | 21.78 | 11.25 | –0.0152 | –0.0134 |
| EoL | 487.98 | 498.22 | 18.97 | 13.51 | –0.0197 | –0.0189 | ||
| MoL | 476.63 | 477.05 | 20.90 | 15.82 | –0.0201 | –0.0193 | ||
| Sal | BoL | 47.97 | 44.53 | 1.84 | 1.12 | –0.0145 | –0.0128 | |
| EoL | 48.89 | 48.88 | 1.70 | 1.28 | –0.0204 | –0.0198 | ||
| MoL | 47.55 | 47.01 | 1.76 | 1.53 | –0.0205 | –0.0198 | ||
Reference-scaled PBE criteria used if denoted by R, otherwise constant-scaled criteria used.
R, reference; Sal, salmeterol; T, test.