TABLE 2.
PK metrics as calculated using observed in vivo PK data and simulated PK, following administration of three lots of a potential generic version of tiotropium bromide inhalation powder with a strength of Eq 0.018 mg Base/inh, where Lots A, B, and C have measured fine‐particle doses of 3.39 μg, 3.37 μg, and 4.45 μg, respectively.
| C max (pg/ml) | t max (h) | AUC0–72h (pg‐h/ml) | |
|---|---|---|---|
| Observed, Lot A | 22.41 | 0.1 | 99.84 |
| Simulated, Lot A | 27.35 | 0.1 | 102.22 |
| Observed, Lot B | 21.71 | 0.1 | 100.47 |
| Simulated, Lot B | 28.26 | 0.1 | 101.77 |
| Simulated, Lot C | 37.81 | 0.1 | 129.72 |
Abbreviations: AUC0–72h, area under the plasma concentration‐time curve from 0 to 72 h; C max, maximum concentration; PK, pharmacokinetics; t max, time to maximum concentration.