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Hi Hötzi,
should we submit a dataset to EMA and suggest them to publish it along with a description (numerical example) of how exactly they wish to derive the decision?
When FDA indicated that they were going in the direction of in vitro popBE for inhalanda and nasal sprays they published a dataset and showed exactly how to process the data to figure out the pass / fail criterion that satisfies the regulator. If EMA would do the same here we'd have all doubt eliminated.
I think we need to know exactly:
1. Do we use nonparametrics or not?
2. Do we use logs or not?
3. Is the decision of 20% comparability based on a confidence interval or on something else?
3a. If there is a CI involved, is it a 90% or 95% CI or something else?
4. Are we primarily working on ratio or on a difference?
5. Is the bootstrap involved?
6. How should we treat datasets from parallel trials, and how should we treat data from XO (i.e. how to handle considerations of paired and non-paired options)?
My gut feeling is that they want nonparametrics for the Tmax comparability part (yes I am aware of the sentence).
If we submit a dataset, let us make sure we submit one with ties (the one I pasted above had none).
should we submit a dataset to EMA and suggest them to publish it along with a description (numerical example) of how exactly they wish to derive the decision?
When FDA indicated that they were going in the direction of in vitro popBE for inhalanda and nasal sprays they published a dataset and showed exactly how to process the data to figure out the pass / fail criterion that satisfies the regulator. If EMA would do the same here we'd have all doubt eliminated.
I think we need to know exactly:
1. Do we use nonparametrics or not?
2. Do we use logs or not?
3. Is the decision of 20% comparability based on a confidence interval or on something else?
3a. If there is a CI involved, is it a 90% or 95% CI or something else?
4. Are we primarily working on ratio or on a difference?
5. Is the bootstrap involved?
6. How should we treat datasets from parallel trials, and how should we treat data from XO (i.e. how to handle considerations of paired and non-paired options)?
My gut feeling is that they want nonparametrics for the Tmax comparability part (yes I am aware of the sentence).
Actually, perhaps they just want the decision taken on basis of the estimates of medians and ranges from min to max?
If we submit a dataset, let us make sure we submit one with ties (the one I pasted above had none).
—
Pass or fail!
ElMaestro
Pass or fail!
ElMaestro
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