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Dear all,
we have performed a comparative study or two atenolol formulations in a
group of 24 health Spanish subjets. One of them was a generic
formulation and the reference has been Tenormin. The dosis was 100 mg.
The two products are equivalent, however we have found values of area
under the plasma concentration-time curve, AUC, relatively larger (about
7500 ng h/mL) than those reported in the literature (about 5000 ng
h/mL). Althout the variability of this parameter is large, we are not
sure if the differece could be atributed to the variability. We have
found a paper (Peh KK, 1999) with a value of AUC similar to our value,
but in asiatic population, and perhaps it is not comparable to caucasian
population.
I would appreciate any suggestion about that, or if someone have any
reference about studies of atenolol with this values of AUC.
Best regards
Alicia Rodriguez
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Dear Alicia:
Many questions need answers. Some of them are (1) what is the proportion of
values that are high (higher than normally observed); (2) is there any ethnic
"groups" difference that may explain high values for Spanish. (3) are the
high values appear in both formulations (4) did you run the equivalence test
on (log) transformed values or untransfomed values (5) what was the
experimental design and what was the statistical procedure did you used (6)
what is the sample size?
Obviously, since the two formulations were equivalent, then the high values
MAY have affect the test for equivalence, especially if untransfomed values
were used.
Best regards,
Louis
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Is the assay in your bioequivalence study comparable to the assay used in the
publication that you compare your PK data with. Assay differences, among
other variables, could potentially lead to the observed differences between
yours and the published data.
Andrej Skerjanec, PhD
Lilly Laboratory for Clinical Research
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