Oral Dispersible Tablet BE study USFDA submission [Regulatives / Guidelines]

posted by Ramesh Ramalingam  – India, 2018-04-13 10:52  – Posting: # 18679
Views: 1,400

Dear All,

Till now , FDA has not issued the general invivo BE study recommendation to conduct the ODT (oral Dispersible Tablet) BE study. Could any one please suggest the drug administration procedure for oral Dispersible Tablet in bioequivalence study (If product specific BE study recommendation not issued).

:confused:

Regards,
Ramesh.R:

Complete thread:

Activity
 Mix view
Bioequivalence and Bioavailability Forum |  Admin contact
19,490 posts in 4,135 threads, 1,335 registered users;
online 14 (0 registered, 14 guests [including 9 identified bots]).
Forum time (Europe/Vienna): 13:10 CEST

Not to be absolutely certain is, I think,
one of the essential things in rationality.    Bertrand Russell

The BIOEQUIVALENCE / BIOAVAILABILITY FORUM is hosted by
BEBAC Ing. Helmut Schütz
HTML5