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We have run a BE study at our top dose level. The top dose consists of 3 tablets taken at once. The
study showed equivalence to material used in a previous study. Going forward we will be dosing at
the top dose as well as two lower doses. The two lower doses will consist of one or two tablets
taken at once.
Are we required to show BE via a human trail at the lower doses too?
In vitro, the dissolution profiles look equivalent.
The drug if fairly proportional at these doses based on the older material (AUC/dose plots have a R
of ~ 0.988). The very slight shift from a proportional increase is thought to be from absorption
limited not solubility limited issues (we have data from even higher doses where non-linearity is
very evident and absorption limits seem to be the cause based on the dissolution profiles compared
to the PK).
Any thoughts or papers/links on this topic would be appreciated.
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