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posted by Helmut 
– Vienna, Austria, 2022-07-28 16:43 (311 d 08:27 ago) – Posting: # 23186
Views: 1,501
Hi Ohlbe & all,
sorry to excavate this corpse (I submitted my comments last Sunday; 34 pages…)
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:
Funny enough the PKWP’s own statement didn’t make it to guidance of May 2018.
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]](https://static.bebac.at/pics/Blue_and_yellow_ribbon_UA.png)
Helmut Schütz
![[image]](https://static.bebac.at/img/CC by.png)
The quality of responses received is directly proportional to the quality of the question asked. 🚮
Science Quotes
Dif-tor heh smusma 🖖🏼 Довге життя Україна!
Helmut Schütz
The quality of responses received is directly proportional to the quality of the question asked. 🚮
Science Quotes
Complete thread:
- EMA: New product-specific guidances Helmut 2022-04-08 15:17
![[Mix]](https://static.bebac.at/img/mix.png "open in Mix view")
- How would you implement it? ElMaestro 2022-04-09 11:45
- Confuse a Cat Inc. Helmut 2022-04-09 18:40
- Confuse a Cat Inc. ElMaestro 2022-04-09 21:47
- Confuse a Cat Inc. Ohlbe 2022-04-11 11:29
- Confuse a Cat Inc. Helmut 2022-04-11 13:59
- So many questions, so few answers Helmut 2022-04-11 13:03
- Preliminary simulations Helmut 2022-04-30 14:59
- Preliminary simulations ElMaestro 2022-04-30 19:10
- Preliminary simulations Helmut 2022-05-01 15:56
- Preliminary simulations ElMaestro 2022-04-30 19:10
- Simulated distributions Helmut 2022-05-02 13:43
- Confuse a Cat Inc. Ohlbe 2022-04-11 11:29
- Confuse a Cat Inc. ElMaestro 2022-04-09 21:47
- Confuse a Cat Inc. Helmut 2022-04-09 18:40
- How would you implement it? ElMaestro 2022-04-09 11:45
Ing. Helmut Schütz