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Dear all,
Is there anyone who had experience with bioequivalence studies
between two different formulations (modified-release) by
administrating 3 tablets in one side and one tablet in the other side
(to have the same dose). What are the chances to demonstrate
bioequivalence with different number of tablets (but the same dose)
considering all the factors that could influence the absorption process.
Many thanks,
Samia
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Dear Samia,
The only possibility that the gastric emptying pattern may be different
in the 2 cases and that may lead to some variability. But this depends
on the kind of molecule you are dealing with. In case you have a drug
that has window of absorption, you may specifically face these
variations and surprises. It is possible to get both Cmax and AUC point
estimates and CIs qualifying for such a study where the drug has +90%
bio-availability and is absorbed through out.
Good luck!!
Manoj K. Paruthi
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