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RegisterEMA: New product-specific guidances [BE/BA News]
posted by Helmut 
– Vienna, Austria, 2022-04-08 17:17 (1189 d 04:02 ago) – Posting: # 22918
Views: 14,253
Dear all,
on April 04 the EMA published revised draft product-specific guidances for ibuprofen, paracetamol, and tadalafil. In the footnote on page 1 we find:
See this article why I consider this invention crap.
In short: tmax follows a discrete distribution on an ordinal scale. Calculating the ratio of values is a questionable procedure (strictly speaking not an allowed operation at all: Only addition, subtraction, ranking are).
![[image]](https://static.bebac.at/img/clock1.svg)
End of consultation 31 July 2022.
on April 04 the EMA published revised draft product-specific guidances for ibuprofen, paracetamol, and tadalafil. In the footnote on page 1 we find:
* This revision concerns defining what is meant by ‘comparable’ Tmax as an additional main pharmacokinetic variable in the bioequivalence assessment section of the guideline.
Then:Bioequivalence assessment: Comparable median (≤ 20% difference) and range for Tmax.
See this article why I consider this invention crap.
In short: tmax follows a discrete distribution on an ordinal scale. Calculating the ratio of values is a questionable procedure (strictly speaking not an allowed operation at all: Only addition, subtraction, ranking are).
End of consultation 31 July 2022.—
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 guidancesHelmut 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
- Revisions of the PSGLs final Helmut 2023-06-23 13:29
- Revisions of the PSGLs final dshah 2023-06-28 14:43
- EMA: No problems with many sampling time points… Helmut 2023-06-28 15:59
- New simulations & some desultory thoughts Helmut 2023-06-29 11:34
- SCNR. A heretic alternative. Helmut 2023-06-30 11:50
- Revisions of the PSGLs final dshah 2023-06-28 14:43
- 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