ODT in BE study [Design Issues]

posted by Farmacevt – North Macedonia, 2022-01-18 17:01 (315 d 15:03 ago) – Posting: # 22732
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Dears,

I would appreciate if you can share your opinion regarding this particular case:

IF you develop generic orodispersible tablet (ODT) and the reference formulation is immediate release tablet (obviously it can be administrate only with water) is it enough to perform two way cross-over study where the ODT will be administrated without water and the reference tbl. with water, or 3 arm study (ODT administrated in both ways with and without water and the reference with water) should be performed?


Thank you

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