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

posted by JP2030 – Saudi Arabia, 2023-10-18 07:58 (572 d 05:14 ago) – Posting: # 23763
Views: 3,222

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.

Regards,
JP2030

Complete thread:

UA Flag
Activity
 Admin contact
23,424 posts in 4,927 threads, 1,671 registered users;
128 visitors (0 registered, 128 guests [including 5 identified bots]).
Forum time: 13:13 CEST (Europe/Vienna)

If you shut your door to all errors
truth will be shut out.    Rabindranath Tagore

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