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RegisterFlawed evaluation accepted [RSABE / ABEL]
Dear Helmut,
It appears quite interesting. I again disagree with you.
Your approach is very questionable.
The sponsor risked and won. We are discussing a specific case. The decision tree may have been questionable, but the questionable part was never implemented. Now, let's imagine that regulators reject the study. But what reason? The reason would be that potentially, in another reality, the results could have been non-equivalent or TIE would be unacceptably high. Also one should take into consideration that at present there are no guidelines or other formal documents that prohibit the usage of this decision tree or require to control TIE and calculate the RR for the ref product first. The local NCA and ethics approved the study. In other words, the study should have been rejected because of an imaginary situation that never materialized in reality. But this approach can more or less be applied to any BE study. It is non-sense and not legally defendable. The only result would be money of taxpayers paid to the sponsor for delayed registration if this would take place in the developed world. Everything that may be a reason to reject studies should explicitly be stated in regulatory documents.
Best regards
It appears quite interesting. I again disagree with you.
Your approach is very questionable.
The sponsor risked and won. We are discussing a specific case. The decision tree may have been questionable, but the questionable part was never implemented. Now, let's imagine that regulators reject the study. But what reason? The reason would be that potentially, in another reality, the results could have been non-equivalent or TIE would be unacceptably high. Also one should take into consideration that at present there are no guidelines or other formal documents that prohibit the usage of this decision tree or require to control TIE and calculate the RR for the ref product first. The local NCA and ethics approved the study. In other words, the study should have been rejected because of an imaginary situation that never materialized in reality. But this approach can more or less be applied to any BE study. It is non-sense and not legally defendable. The only result would be money of taxpayers paid to the sponsor for delayed registration if this would take place in the developed world. Everything that may be a reason to reject studies should explicitly be stated in regulatory documents.
Best regards
Complete thread:
- Statistical evaluation and BE hypotheses in full replicate design Elena777 2020-01-28 07:02
![[Mix]](https://static.bebac.at/img/mix.png "open in Mix view")
- Inflation of the TIE as well Helmut 2020-01-29 15:38
- Inflation of the TIE as well Elena777 2020-01-29 20:01
- Tricky… Helmut 2020-01-30 12:07
- Tricky… Mikalai 2020-01-30 13:08
- Terrible… Helmut 2020-01-30 15:09
- Flawed evaluation accepted Helmut 2020-01-31 12:19
- Flawed evaluation accepted Mikalai 2020-01-31 12:40
- Flawed evaluation accepted Helmut 2020-01-31 14:17
- Flawed evaluation acceptedMikalai 2020-01-31 16:41
- Flawed approach even if accepted ? Helmut 2020-01-31 20:28
- Flawed approach even if accepted ? Mikalai 2020-02-01 16:18
- misunderstanding mittyri 2020-02-01 21:34
- misunderstanding Mikalai 2020-02-06 13:41
- misunderstanding mittyri 2020-02-06 16:23
- misunderstanding Mikalai 2020-02-06 13:41
- The globe is flat! d_labes 2020-02-05 19:16
- misunderstanding mittyri 2020-02-01 21:34
- Flawed approach even if accepted ? Mikalai 2020-02-01 16:18
- Flawed approach even if accepted ? Helmut 2020-01-31 20:28
- Flawed evaluation acceptedMikalai 2020-01-31 16:41
- Flawed evaluation accepted Helmut 2020-01-31 14:17
- Flawed evaluation accepted Mikalai 2020-01-31 12:40
- Tricky… wienui 2020-01-30 18:53
- Tricky… Helmut 2020-01-30 19:18
- Tricky… wienui 2020-02-03 07:10
- ABE vs. ABEL Helmut 2020-02-03 12:25
- zigzag d_labes 2020-02-05 18:53
- zigzag Helmut 2020-02-05 19:46
- zigzag Mikalai 2020-02-06 11:38
- helter-skelter Helmut 2020-02-06 20:12
- helter-skelter Mikalai 2020-02-10 16:10
- helter-skelter Helmut 2020-02-06 20:12
- zigzag Mikalai 2020-02-06 11:38
- zigzag Helmut 2020-02-05 19:46
- zigzag d_labes 2020-02-05 18:53
- ABE vs. ABEL Helmut 2020-02-03 12:25
- Tricky… wienui 2020-02-03 07:10
- Tricky… Helmut 2020-01-30 19:18
- Tricky… Mikalai 2020-01-30 13:08
- Tricky… Helmut 2020-01-30 12:07
- Inflation of the TIE as well zizou 2020-02-01 17:00
- Inflation of the TIE as well nobody 2020-02-01 23:30
- Inflation of the TIE as well Elena777 2020-03-10 19:28
- Fishing in the dark Helmut 2020-03-10 21:06
- Inflation of the TIE as well Elena777 2020-01-29 20:01
- Statistical evaluation and BE hypotheses in full replicate design nobody 2020-02-03 15:07
- TIE, repeat once more please... Astea 2020-04-02 12:41
- Inflation of the TIE as well Helmut 2020-01-29 15:38
Ing. Helmut Schütz