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Hi Hötzi,
your post is potentially highly significant.
The intention, as I understand it, was exactly the opposite. It goes completely against all intention, doesn't it?
I think this knowledge, if it holds in confirmatory simulations, should be published quickly and made available to regulators.
I very much hope that regulators will abstain completely from letting pride prevail over the regard for the EU patient. So I hope they will not dismiss the argumentation. For example, I could fear they would dismiss your findings because they don't have a palate for simulations (but note they like simulations well enough when it comes to f2; bootstrapping is a simulation, too).
your post is potentially highly significant.
❝ Is this really the intention? The wider the range in tmax, the more easily products will pass. Counterintuitive.
The intention, as I understand it, was exactly the opposite. It goes completely against all intention, doesn't it?
I think this knowledge, if it holds in confirmatory simulations, should be published quickly and made available to regulators.
I very much hope that regulators will abstain completely from letting pride prevail over the regard for the EU patient. So I hope they will not dismiss the argumentation. For example, I could fear they would dismiss your findings because they don't have a palate for simulations (but note they like simulations well enough when it comes to f2; bootstrapping is a simulation, too).
—
Pass or fail!
ElMaestro
Pass or fail!
ElMaestro
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 simulationsElMaestro 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 simulationsElMaestro 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