Bioequivalence and Bioavailability Forum

Main page Policy/Terms of Use Abbreviations Latest Posts

 Log in |  Register |  Search

Back to the forum  2018-06-22 19:30 CEST (UTC+2h)

Truncted AUC, or AUCinf, which one [Design Issues]

posted by ElMaestro - Denmark, 2017-08-17 10:47  - Posting: # 17705
Views: 2,544

Hi again ssussu,

» Then if I choose truncated AUC0-72 instead of AUClast and AUCinf in the protocol,while most of the subjects half-life is not long enough (i.e 18hr) , actually, in this situation, it is possible the time point of 72hr sample concentration is BQL or can not be detected, then what I shoud do?

Well... it would be a bit unusual to this often when the drug generally has an excessive long half-life but OK it might happen. Between-subject variability etc.
You may need to invest at least 90 seconds of your time in figuring this one out with pen and paper. You have some subjects that go below the LLOQ, which means they comfortably display an elimination phase. From those subjects you can routinely derive an elimination constant and extrapolate AUClast (least measurable) to AUCinfinity. This is where you sadly need to invest this obscenely large amount of your precious time: use the same logic and jommetry and extrapolate areas to 72 hrs. in stead of infinity. You'll end up with a full data listing of AUC72 estimates, and Bob's your uncle.
Good luck.

if (3) 4

Best regards,
ElMaestro

"(...) targeted cancer therapies will benefit fewer than 2 percent of the cancer patients they’re aimed at. That reality is often lost on consumers, who are being fed a steady diet of winning anecdotes about miracle cures." New York Times (ed.), June 9, 2018.

Complete thread:

Back to the forum Activity
 Mix view
Bioequivalence and Bioavailability Forum |  Admin contact
18,418 posts in 3,912 threads, 1,173 registered users;
online 17 (0 registered, 17 guests [including 8 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