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Hi ElMaestro,
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.
❝ 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
Regards
Ohlbe
Complete thread:
- EMA: New product-specific guidances Helmut 2022-04-08 15:17 [BE/BA News]
![[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