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RegisterRussian «Экспертами» following the EEU GLs [Regulatives / Guidelines]
Dear all
My name is Mikalai, and I am responsible for the conduct of bioequivalence studies in a medium-sized private pharmaceutical company in Belarus. Due to logistic issues (a small clinical center and a highly variable drug) we have to conduct a bioequivalence study in multiple groups (two). Our competent authority requires a justification not to include the group effect in the proposed statistical model. The groups will be separated by a week at maximum. It seems that we meet criteria set out by FDA to use a statistical model without including the group effect. Our competent authority can accept the FDA position on this issue, but we should properly reference it.
Thus, where can I find this information under FOI (link) or might it be possible that someone can share a copy of letter signed by Barbara Davit where it is outlined requirements to ignore the group effect in a statistical model?
Any help will be appreciated.
Sincerely, Mikalai
Edit: I moved your post from an answer to this one, deleted your email address, and activated personal messages in your profile instead. [Helmut]
My name is Mikalai, and I am responsible for the conduct of bioequivalence studies in a medium-sized private pharmaceutical company in Belarus. Due to logistic issues (a small clinical center and a highly variable drug) we have to conduct a bioequivalence study in multiple groups (two). Our competent authority requires a justification not to include the group effect in the proposed statistical model. The groups will be separated by a week at maximum. It seems that we meet criteria set out by FDA to use a statistical model without including the group effect. Our competent authority can accept the FDA position on this issue, but we should properly reference it.
Thus, where can I find this information under FOI (link) or might it be possible that someone can share a copy of letter signed by Barbara Davit where it is outlined requirements to ignore the group effect in a statistical model?
Any help will be appreciated.
Sincerely, Mikalai
Edit: I moved your post from an answer to this one, deleted your email address, and activated personal messages in your profile instead. [Helmut]
Complete thread:
- Russian «Экспертами» and their hobby Helmut 2017-04-29 00:46 [Regulatives / Guidelines]
![[Mix]](https://static.bebac.at/img/mix.png "open in Mix view")
- Low power of Group-by-Treatment interaction mittyri 2017-04-29 22:57
- Let’s forget the Group-by-Treatment interaction, please! Helmut 2017-04-30 13:54
- Let’s forget the Group-by-Treatment interaction, please! ElMaestro 2017-05-01 16:19
- Some answers Helmut 2017-05-02 01:10
- Some answers ElMaestro 2017-05-02 09:04
- Example Helmut 2017-05-02 12:35
- Sensitivity of term? mittyri 2017-05-02 18:29
- Simulations Helmut 2017-05-05 14:38
- loosing specificity due to low sensitivity mittyri 2017-05-08 23:28
- loosing specificity due to low sensitivity Helmut 2017-05-09 00:55
- loosing specificity due to low sensitivity mittyri 2017-05-08 23:28
- Loss in power Helmut 2017-05-06 17:31
- Interval between groups Helmut 2017-05-08 19:02
- IMP handling mittyri 2017-05-08 23:40
- IMP handling Helmut 2017-05-09 01:08
- IMP handling mittyri 2017-05-08 23:40
- Loss in power Helmut 2017-05-14 17:22
- Simulations Helmut 2017-05-05 14:38
- Some answers ElMaestro 2017-05-02 09:04
- No convergence in JMP and Phoenix WinNonlin Helmut 2017-05-25 15:26
- Ouch?!??? ElMaestro 2017-05-25 16:24
- Some answers Helmut 2017-05-02 01:10
- Let’s forget the Group-by-Treatment interaction, please! ElMaestro 2017-05-01 16:19
- Let’s forget the Group-by-Treatment interaction, please! Helmut 2017-04-30 13:54
- Russian «Экспертами» and their hobby Artem Gusev 2017-05-02 16:13
- be careful with mixed models mittyri 2017-05-02 17:53
- be careful with mixed models Artem Gusev 2017-05-03 11:02
- p-value(s) in model 2 Helmut 2017-05-05 14:48
- be careful with mixed models mittyri 2017-05-02 17:53
- Russian «Экспертами» following the EEU GLs Helmut 2017-05-24 20:17
- Russian «Экспертами» following the EEU GLs Beholder 2017-05-24 22:37
- Penalty for carelessness mittyri 2017-05-25 08:52
- Russian «Экспертами» following the EEU GLs Beholder 2017-05-25 10:43
- Russian «Экспертами» following the EEU GLsMikalai 2018-01-04 10:43
- Belarus = member of the EEU Helmut 2018-01-04 13:08
- Belarus = member of the EEU Mikalai 2018-01-04 19:49
- Trying your model for EEU mittyri 2018-01-04 22:04
- Trying your model for EEU Helmut 2018-01-05 00:06
- help us to stop it, please... Astea 2018-01-10 12:09
- help us to stop it, please... Beholder 2018-01-10 12:49
- regulators convinced by science? d_labes 2018-01-10 15:15
- regulators convinced by science? Beholder 2018-01-10 17:14
- Чёрт побери! d_labes 2018-01-10 18:53
- regulators convinced by science? Astea 2018-01-10 19:10
- regulators convinced by science? Beholder 2018-01-10 17:14
- help us to stop it, please... Astea 2018-01-10 12:09
- Trying your model for EEU Helmut 2018-01-05 00:06
- Belarus = member of the EEU Helmut 2018-01-04 13:08
- Russian «Экспертами» following the EEU GLs Beholder 2017-05-24 22:37
- Low power of Group-by-Treatment interaction mittyri 2017-04-29 22:57
Ing. Helmut Schütz