BE-proff
★★  

Russia,
2018-12-24 17:58

Posting: # 19714
Views: 1,058
 

 AUC or Cmax for RSABE? [Power / Sample Size]

Hi All,:ok:

let's say I want to conduct a BE study using RSABE (EMA).
From previous studies I have both AUCs and Cmax with their GMR and CVintra.

Which parameter is better for sample size calculation - AUC or Cmax?
mittyri
★★  

Russia,
2018-12-24 21:33

@ BE-proff
Posting: # 19715
Views: 864
 

 Take them both

Hi BE-proff,

» From previous studies I have both AUCs and Cmax with their GMR and CVintra.
» Which parameter is better for sample size calculation - AUC or Cmax?

You need to take into account both.
Remember this one? ;-)
The leading metric depends on CV and GMR.

Kind regards,
Mittyri
Activity
 Thread view
Bioequivalence and Bioavailability Forum |  Admin contact
19,883 posts in 4,214 threads, 1,365 registered users;
online 11 (0 registered, 11 guests [including 4 identified bots]).
Forum time (Europe/Vienna): 19:59 CEST

Competence, like truth, beauty and contact lenses,
is in the eye of the beholder.    Laurence J. Peter

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