AUCrefTmax (Health Canada) [Regulatives / Guidelines]
- Rapid onset of effect is important. According to the guidance AUCrefTmax should be reported. IMHO, a statistical comparison is not required.
- What does you protocol say?
Thank you for the note.
section 18.104.22.168, reads about AUCrefTmax and its relative mean area of Test and Ref to be in 80-125%. Correct me if I am wrong. Here I understood 90% CI is not required. Only point estimate has to be with in 80 to 125%
Protocol is slient on AUCrefTmax.
Edit: Full quote removed. Please delete everything from the text of the original poster which is not necessary in understanding your answer; see also this post #5! [Helmut]