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

posted by Ramesh Ramalingam  – India, 2018-04-13 12:52 (2261 d 07:01 ago) – Posting: # 18679
Views: 2,965

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).



Complete thread:

UA Flag
 Admin contact
23,059 posts in 4,841 threads, 1,664 registered users;
37 visitors (0 registered, 37 guests [including 4 identified bots]).
Forum time: 19:53 CEST (Europe/Vienna)

[…] an inappropriate study design is incapable of answering
a research question, no matter how careful the subsequent
methodology, conduct, analysis, and interpretation:
Flawless execution of a flawed design achieves nothing worthwhile.    J. Rick Turner

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