CI inclusion ≠ TOST [Regulatives / Guidelines]

posted by ElMaestro  – Denmark, 2020-12-05 16:49 (41 d 13:06 ago) – Posting: # 22118
Views: 682


» if the CI inclusion rule is really something different than TOST why do we calculate power / samplesize based on TOST :confused:.

d_labes, you beat me to it, I was going to ask a similar question. :-D

If I am getting it right this isn't about whether your product passes the test for BE or not, it is purely a matter relating to what you call it. Since semantics is now of such importance, I believe PowerTOST needs to be renamed.:cool:

Now someone kindly define robust and robustness for me so that I understand it. And please tell me how to use that definition to make a simulation robust enough that it convinces WHO :-)
Or more generally, if I want to present an argument to a WHO regulator (not a simulation but just an argument which may or may not be based on siumulation) in which way will I know away to make my argument robust?

Pass or fail!

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