ODT in BE study [Design Issues]

posted by Farmacevt – North Macedonia, 2022-01-18 17:01 (315 d 15:03 ago) – Posting: # 22732
Views: 844


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

Complete thread:

UA Flag
 Admin contact
22,418 posts in 4,693 threads, 1,598 registered users;
14 visitors (0 registered, 14 guests [including 6 identified bots]).
Forum time: 08:05 CET (Europe/Vienna)

Intellect distinguishes between the possible and the impossible;
reason distinguishes between the sensible and the senseless.
Even the possible can be senseless.    Max Born

The Bioequivalence and Bioavailability Forum is hosted by
BEBAC Ing. Helmut Schütz