tmax in EEA applications [Surveys]

posted by Helmut Homepage – Vienna, Austria, 2013-06-22 20:40 (3626 d 14:16 ago) – Posting: # 10865
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Dear all,

with the IR GL operational for almost three years now and the MR GL approaching (see also this post) I’m curious what is your practice. I’m talking only about formulations where tmax is clinical relevant (mostly rapid onset, rarely AE related).
We all know that “A statistical evaluation of tmax is not required.” Does that mean that it is not accept­able as well? I read that “A non-parametric analysis is not acceptable”, but

<nitpicking>
this paragraph is related to ANOVA and log-transformation.
</nitpicking>

“[…] there should be no apparent* difference in median tmax and its X between test and reference product.”
where X = “variability” (IR GL) and “range” (MR draft).

My practice (as it was since the mid 1980s):Experience so far: no problems.

Questions:
1. What do you do now? _____________
2. Do you consider changing your practice in the near future? [ ] yes [ ] no
3. If yes, what are you planning to do? _____________



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