Exponentiated (ie, back-transformed) differences and 90% CI (part 2)
. | Exp (O-IV)∗ . | 90% CI† . | |
---|---|---|---|
PKAS | |||
AUC0-24 WB | 0.993 | 0.954-1.034 | |
AUC0-24 PL | 1.030 | 0.977-1.087 | |
Cmax WB | 0.917 | 0.871-0.966 | |
Cmax PL | 0.969 | 0.892-1.053 | |
mPKAS | |||
AUC0-24 WB | 1.023 | 0.978-1.071 | |
AUC0-24 PL | 1.051 | 0.996-1.108 | |
Cmax WB | 0.934 | 0.886-0.984 | |
Cmax PL | 0.982 | 0.913-1.056 |
. | Exp (O-IV)∗ . | 90% CI† . | |
---|---|---|---|
PKAS | |||
AUC0-24 WB | 0.993 | 0.954-1.034 | |
AUC0-24 PL | 1.030 | 0.977-1.087 | |
Cmax WB | 0.917 | 0.871-0.966 | |
Cmax PL | 0.969 | 0.892-1.053 | |
mPKAS | |||
AUC0-24 WB | 1.023 | 0.978-1.071 | |
AUC0-24 PL | 1.051 | 0.996-1.108 | |
Cmax WB | 0.934 | 0.886-0.984 | |
Cmax PL | 0.982 | 0.913-1.056 |
Exp, exponentiated; O, oral.
The Exp difference in the means of the logs is an estimate of the ratio of the geometric means of each PK parameter.
When the 90% CI lies entirely within the interval (0.80-1.25) the null hypothesis of nonequivalence is rejected using the TOST procedure, and average bioequivalence can be claimed.