Table 4.

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.

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