Range [BE/BA News]

posted by Helmut Homepage – Vienna, Austria, 2022-07-28 16:43 (311 d 08:27 ago) – Posting: # 23186
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Hi Ohlbe & all,

sorry to excavate this corpse (I submitted my comments last Sunday; 34 pages…)

❝ Are they using the word in its statistical meaning (difference between the largest and smallest values) or in its lay language meaning (limits between which something varies) ? I suspect the latter: lowest and highest observed Tmax values.

Discovered another one. In the first draft (EMA/CHMP/356876/2017 of July 2017) the bizarre “Comparable median and range for Tmax” was given.
Stakeholders asked for a clarification and in the comments (EMA/CHMP/730723/2017 of May 2018) we find:

Tmax is not an end point to be included in the statistical analysis but a comparison of the values should be made and any differences discussed in the context of the application (see later).

This response could be understand that a comparison of tmax should only be discussed. Regrettably there was nothing to be ‘seen later’.
Funny enough the PKWP’s own statement didn’t make it to guidance of May 2018.

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