Farmacevt
☆    

North Macedonia,
2022-01-18 17:01
(379 d 03:30 ago)

Posting: # 22732
Views: 960
 

 ODT in BE study [Design Issues]

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
dshah
★★  

India/United Kingdom,
2022-01-18 20:08
(379 d 00:24 ago)

@ Farmacevt
Posting: # 22733
Views: 768
 

 ODT in BE study

Dear Farmacevt!
It is advisable to perform 3 way BE study i.e.- with and without water for ODT and Reference with water. This will also have advantage to prove that there is no significant difference in PK for ODT when administered with and without water.
Regards,
Dshah
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