Confuse a Cat Inc. [BE/BA News]

posted by Ohlbe – France, 2022-04-11 11:29 (35 d 08:48 ago) – Posting: # 22923
Views: 862

Hi ElMaestro,

» My gut feeling is that they want nonparametrics for the Tmax comparability part (yes I am aware of the sentence).

My gut feeling is that all they expect to get are descriptive statistics: report median Tmax for Test, median Tmax for Reference, calculate a % difference (however inappropriate this may be), pass if it is not more than 20%, otherwise fail.

Consequence: if you have more than 20% difference between sampling times around the expected Tmax, you're screwed if median Tmax values are different even by just one sampling time, even if this has strictly no clinical relevance (this could be brought up in the comments to the draft guideline: come on guys, are you sure a Tmax of 10' for one formulation and 15' for the other is really something totally unacceptable ? I mean, even for tadalafil you should be able to keep yourself busy until it works).

Range: no expectation described. No idea.

Of course I may be totally wrong.

Regards
Ohlbe

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