Range [BE/BA News]

posted by Helmut Homepage – Vienna, Austria, 2022-07-28 16:43 (803 d 17:23 ago) – Posting: # 23186
Views: 5,589

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.
—
Dif-tor heh smusma 🖖🏼 Довге життя Україна! [image]
Helmut Schütz
[image]

The quality of responses received is directly proportional to the quality of the question asked. 🚮
Science Quotes

Complete thread:

UA Flag
Activity
 Admin contact
23,249 posts in 4,885 threads, 1,653 registered users;
76 visitors (0 registered, 76 guests [including 13 identified bots]).
Forum time: 10:06 CEST (Europe/Vienna)

I have never in my life learned anything
from any man who agreed with me.    Dudley Field Malone

The Bioequivalence and Bioavailability Forum is hosted by
BEBAC Ing. Helmut Schütz
HTML5