JP2030
☆    

Saudi Arabia,
2023-10-18 07:58
(572 d 07:36 ago)

Posting: # 23763
Views: 3,224
 

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

Post reply
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
 
Helmut
★★★
avatar
Homepage
Vienna, Austria,
2023-10-18 09:09
(572 d 06:25 ago)

@ JP2030
Posting: # 23764
Views: 2,548
 

 EMA: No AUC(0-72h) for all MR products

Post reply
Hi JP2030,

❝ 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.

See the applicable guideline page 25:

A truncated AUC(0-72h) is not acceptable for MR products.

On page 26:

Single dose: AUC(0-t), AUC(0-∞), Cmax

Scientifically this does not make sense for DR products…
—
Dif-tor heh smusma 🖖🏼 Довге життя Україна! [image]
Helmut Schütz
[image]

The quality of responses received is directly proportional to the quality of the question asked. 🚮
Science Quotes
 
UA Flag
Activity
 Admin contact
23,424 posts in 4,927 threads, 1,671 registered users;
140 visitors (0 registered, 140 guests [including 4 identified bots]).
Forum time: 15:34 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