AUC infinity: primary for the FDA [Study As­sess­ment]

posted by Helmut Homepage – Vienna, Austria, 2017-10-24 19:14 (2347 d 17:27 ago) – Posting: # 17913
Views: 5,584

Salam Mokhtar,

❝ Is AUC0-inf a primary parameter for assessing Bioequivalence or secondary ???


Depends on what is stated in your statistical analysis plan. ;-)
For the FDA you have to demonstrate BE for Cmax, AUC0–t, and AUC0–∞.
In most other jurisdictions only Cmax are AUC0–t required.

❝ […] the C.I of cmax and AUC0-t were in the accepted range of Bioequivalence but AUC0-inf outside the range, can the study be accepted??


In many cases the variability of these PK metrics ranks Cmax > AUC0–∞ > AUC0–t. Hence, passing Cmax but failing AUC0–∞ is unlikely but possible.

❝ Although the drug is not a highly variable drug????


Doesn’t matter.

P.S.: Your keyboard’s ? got jammed numerous times. You should [image] repair or  replace it.

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

Complete thread:

UA Flag
Activity
 Admin contact
22,957 posts in 4,819 threads, 1,636 registered users;
84 visitors (0 registered, 84 guests [including 4 identified bots]).
Forum time: 11:42 CET (Europe/Vienna)

With four parameters I can fit an elephant,
and with five I can make him wiggle his trunk.    John von Neumann

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