Delayed Release For­mu­la­tion -AUC trun­cated at 72 h (AUC(0-72h)) [Regulatives / Guidelines]

posted by JP2030 – Saudi Arabia, 2023-10-18 07:58 (42 d 03:27 ago) – Posting: # 23763
Views: 810

Dear All,

Please share your opinion on Delayed-Release Tablets can we use study design AUC truncated at 72 h (AUC(0-72h)) for EU Submission? It's acceptable.

Terminal Elimination Half-Life (T1/2el) of the drug is 67 hrs.

Thanks in advance for your response.


Complete thread:

UA Flag
 Admin contact
22,811 posts in 4,783 threads, 1,642 registered users;
23 visitors (0 registered, 23 guests [including 9 identified bots]).
Forum time: 10:26 CET (Europe/Vienna)

Every man gets a narrower and narrower field of knowledge
in which he must be an expert in order to compete with other people.
The specialist knows more and more about less and less
and finally knows everything about nothing.    Konrad Lorenz

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