2 replies to this topic

[sundar]

Hello all, 

 

Request your thoughts on minimum number of sampling points requirements for AUEC calculation in Phoenix.

 

Thanks
Sundar. M 

[Simon Davis]

i think that really depends on what your effect is and how much you think it is going to change by, and at what rate.

Also will your primary assessment be NCA or will you also try to model the effect curve?

I think you have to have some idea, from literature of similar studies, understanding if a  placebo model is required etc. e.g. we know body temperature, cortisol etc. vary diurnally.

 

 Simon.

[sundar]

Hi Simon, 

 

Thanks for your reply. 

 

Primary assessment would be based on NCA & PD marker is type I collagen C-telopeptide.

 

I am verifying the adequacy of 4 time points (month 0, 1, 3 & 6) to characterize AUEC. 

 

Your thought is highly appreciated. 

 

Thanks

Sundar. M