Table 2.
Shows a statistical comparison of test and reference products for the area under the curve till time t, maximum plasma concentration achieved, and time to reach maximum plasma concentration
| Variables | Drug | N | Mean ± Std. deviation | Std. error mean | Significance* | TR ratio** |
|---|---|---|---|---|---|---|
|
AUC (µg.h/ml) |
Test | 12 | 27.12 ± 6.02 | 1.74 | t = 0.089, p = 0.93 | 0.99 |
| Reference | 12 | 27.29 ± 2.64 | 0.76 | |||
|
Cmax (µg/ml) |
Test | 12 | 7.42 ± 1.06 | 0.31 | t = 0.89, p = 0.38 | 0.95 |
| Reference | 12 | 7.83 ± 1.19 | 0.34 | |||
|
Tmax (hr) |
Test | 12 | 0.85 ± 0.22 | 0.06 | t = 0.22, p = 0.83 | 1.02 |
| Reference | 12 | 0.83 ± 0.25 | 0.07 |
*p-value is considered significant at < 0.05; ** TR = Test to Reference (Recommended Range 0.80–1.25)