BE-proff
●    

2018-12-24 18:58
(1943 d 09:49 ago)

Posting: # 19714
Views: 2,889
 

 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 22:33
(1943 d 06:14 ago)

@ BE-proff
Posting: # 19715
Views: 2,270
 

 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
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