Bioequivalence and Bioavailability Forum

Main page Policy/Terms of Use Abbreviations Latest Posts

 Log in |  Register |  Search

Back to the forum  2018-06-22 02:27 CEST (UTC+2h)
mokhtar saleh
Junior

Egypt,
2017-10-24 16:58

Posting: # 17912
Views: 1,428
 

 AUC infinity [Study As­sess­ment]

Is AUC0-inf a primary parameter for assessing Bioequivalence or secondary ??? I mean in a Bioequivalence study 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??
Although the drug is not a highly variable drug????


Edit: Please follow the Forum’s Policy. [Helmut]
Helmut
Hero
avatar
Homepage
Vienna, Austria,
2017-10-24 17:14

@ mokhtar saleh
Posting: # 17913
Views: 1,202
 

 AUC infinity: primary for the FDA

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 repair or  replace it.

Cheers,
Helmut Schütz
[image]

The quality of responses received is directly proportional to the quality of the question asked. ☼
Science Quotes
mokhtar saleh
Junior

Egypt,
2017-10-24 18:29

@ Helmut
Posting: # 17914
Views: 1,199
 

 AUC infinity: primary for the FDA

Thank you doctor
But are there any country or guidance stat AUCinf as a primary parameter??


Edit: See this post #3. [Helmut ≠ doctor]
jag009
Hero

NJ,
2017-10-27 05:42

@ mokhtar saleh
Posting: # 17932
Views: 1,060
 

 AUC infinity: primary for the FDA

» But are there any country or guidance stat AUCinf as a primary parameter??

He said that already. FDA=USA needs BE for Cmax, AUCt and AUCi

J
Back to the forum Activity
 Thread view
Bioequivalence and Bioavailability Forum |  Admin contact
18,413 posts in 3,912 threads, 1,175 registered users;
online 34 (0 registered, 34 guests [including 26 identified bots]).

The greatest shortcoming of the human race is our inability
to understand the exponential function.    Albert Bartlett

The BIOEQUIVALENCE / BIOAVAILABILITY FORUM is hosted by
BEBAC Ing. Helmut Schütz
HTML5 RSS Feed