Parameter
Obtained value (confidence limits)
Probability of having outside values
C
max
1.0545
(0.9086 – 1.2239)
<0.80 p=0.0023
>1.25 p=0.0315
AUC
last
1.0192
(0.8562 – 1.2133)
<0.80 p=0.0080
>1.25 p=0.0285
AUC
∞
1.0343
(0.8729 – 1.2256)
<0.80 p=0.0083
>1.25 p=0.0342
Table 2:
Ratio and 90% confidence limits of Cmax, AUClast and AUC∞ to the
formulations tested, as well as, probability of exceeding the limits of acceptance
for bioequivalence.
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