first point Cmax: trouble waiting to happen? [Study As­sess­ment]

posted by Astea – Russia, 2019-03-03 21:42 (597 d 11:34 ago) – Posting: # 19991
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Dear Helmut!

Thank you very much for your response!

That's understandable that the sampling schedule should be planned to avoid Cmax being the first point. But if it has just happened for some (or even for the majority) subjects? "It happens... sometimes" (Forrest)

» My personal summary: First-point Cmax “should be avoided”. Though not elaborated in the section about exclusion, I would state it in the protocol. See also what Ohlbe wrote above. I would gather that excluding >20% of subjects will lead to troubles (similar to high residual AUC).

Can assessors ban the whole study for this reason? So far I was lucky enough not to get any questions from russian assessors, but we are planning to deal with the regulators from other countries. Contrary to the Mann's situation the full data set is BE. I would like to know if there were any precedents of this kind.

"Being in minority, even a minority of one, did not make you mad"

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