Achievwin
☆    

US,
2019-01-24 17:50

Posting: # 19806
Views: 613
 

 Can we have two primary objectives? [Design Issues]

In a BE study (two stage or one stage) are we allowed to have two primary objectives? Let us say either/or objective 1 or Objective 2 meets the BE criteria Bioequivalence is concluded.

Does anyone have experience in OGD entertaining such statistical analysis plan?

Thanks for your suggestions,

AchievWin
ElMaestro
★★★

Belgium?,
2019-01-25 09:55

@ Achievwin
Posting: # 19807
Views: 499
 

 Can we have two primary objectives?

Hi Achievwin,

» In a BE study (two stage or one stage) are we allowed to have two primary objectives? Let us say either/or objective 1 or Objective 2 meets the BE criteria Bioequivalence is concluded.
»
» Does anyone have experience in OGD entertaining such statistical analysis plan?

It is often not a problem to have two objectives, and it is not entirely uncommon to have duality in the analysis but you may need to account for alpha inflation if this protocol allows you "two chances" to show BE.
More details about your design and the nature of your objectives would be necessary before I would dare to come forward with a less vague opinion. For example, do you have two formulations and you hope to show BE for (at least) one of them?

I could be wrong, but...
Best regards,
ElMaestro
Activity
 Thread view
Bioequivalence and Bioavailability Forum |  Admin contact
19,604 posts in 4,158 threads, 1,340 registered users;
online 8 (0 registered, 8 guests [including 4 identified bots]).
Forum time (Europe/Vienna): 17:44 CEST

Nothing in the world is more dangerous
than sincere ignorance
and conscientious stupidity.    Martin Luther King, Jr.

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