ODT in BE study [Design Issues]

posted by dshah  – India/United Kingdom, 2022-01-18 20:08 (384 d 10:40 ago) – Posting: # 22733
Views: 774

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

Complete thread:

UA Flag
Activity
 Admin contact
22,481 posts in 4,710 threads, 1,603 registered users;
23 visitors (0 registered, 23 guests [including 11 identified bots]).
Forum time: 06:49 CET (Europe/Vienna)

The difference between a surrogate and a true endpoint
is like the difference between a cheque and cash.
You can get the cheque earlier but then,
of course, it might bounce.    Stephen Senn

The Bioequivalence and Bioavailability Forum is hosted by
BEBAC Ing. Helmut Schütz
HTML5