Bioequivalence and Bioavailability Forum

Hi Everyone. This member.
I will study about the duloxetine in bioequivalence.


According to the reference, ISCV in AUC and Cmax values was considerable, with the CV ranging from 46.79% to 61.89% and 35.81% to 68.18%, respectively
(Clinical Therapeutics/Volume 31, Number 5, 2009)

Another the reference, ISCV in AUC and Cmax values was small with the CV ranging from 13.29% and 13.16%
(NDA N0. 21-427, Cymbalta)

Finally the reference, ISCV in AUC and Cmax values was small the the CV ranging from 17.12% and 21.99%
(Internal Data)
Fast          AUC(inf)   AUC(t)     Cmax    Tmax
Test(N=47)      521.52    476.62    29.49     6
Reference(N=47) 548.45    512.84    34.28     5
T/R Ratio         0.95      0.93     0.86
90% CI         0.9~1.01  0.88-0.99  0.80~0.93   
Intra CV        16.76%     17.12%   21.99%

Why reference value this different.
I reviewed this product. And this product has pushed me to the chaos.
You please advise to me

Best regards BJ