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I have a note here pertinent to two modified release formulations of diltiazem: one MR formulation
of diltiazem was tested against a marketed immediate reference diltiazem tablet in a single dose
cross-over design. The bioavailability of the MR formulation was 80% vs. IR reference.
A second MR formulation of diltiazem used a different formulation technology to the first one was
evaluated in a second study with the same design, but different subjects as the first one. The dose
levels of test and reference were the same as the first study. The relative bioavailability of the
second formulation to the IR tablet was 65%.
The conclusion given to me is the following: The relative bioavailability of the second MR
formulation to the first MR formulation was 65/80*100 = 81.25%.
What do you think of the conclusion?
Angus McLean.
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