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RegisterInflation of the TIE as well [RSABE / ABEL]
Dear Helmut, still have some doubts regarding decision scheme.
As per you comment:
It seems not only I would like to modify a decision scheme. I saw the following conclusion in the PAR (https://db.cbg-meb.nl/Pars/h116289.pdf).
Conclusion on bioequivalence study
The reference product was found to be highly variable for Cmax with an intra-subject variability greater than 30%: the intra-individual coefficient of variation was 41.62%. Widening of the acceptance intervals for Cmax was allowed but, based on the study results, proved not to be necessary. The 90% confidence intervals calculated for AUC0-t and Cmax are within the bioequivalence acceptance range of 0.80 – 1.25. Based on the submitted bioequivalence study Atorvastatine STADA is considered bioequivalent with Lipitor.
As I understand, they did not use the decision scheme described in the lecture. Otherwise it was obligatory for them to modify CI for Cmax. But they just stated that "widening of the acceptance intervals for Cmax was allowed but, based on the study results, proved not to be necessary".
So, how do you think what decision tree was used in that study?
As per you comment:
❝ you are modifying the common decision scheme. Why?
It seems not only I would like to modify a decision scheme. I saw the following conclusion in the PAR (https://db.cbg-meb.nl/Pars/h116289.pdf).
Conclusion on bioequivalence study
The reference product was found to be highly variable for Cmax with an intra-subject variability greater than 30%: the intra-individual coefficient of variation was 41.62%. Widening of the acceptance intervals for Cmax was allowed but, based on the study results, proved not to be necessary. The 90% confidence intervals calculated for AUC0-t and Cmax are within the bioequivalence acceptance range of 0.80 – 1.25. Based on the submitted bioequivalence study Atorvastatine STADA is considered bioequivalent with Lipitor.
As I understand, they did not use the decision scheme described in the lecture. Otherwise it was obligatory for them to modify CI for Cmax. But they just stated that "widening of the acceptance intervals for Cmax was allowed but, based on the study results, proved not to be necessary".
So, how do you think what decision tree was used in that study?
Complete thread:
- Statistical evaluation and BE hypotheses in full replicate design Elena777 2020-01-28 07:02 [RSABE / ABEL]
![[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 accepted Mikalai 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 accepted Mikalai 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 wellElena777 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