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RegisterBelarus = member of the EEU [Regulatives / Guidelines]
Dear Helmut,
Thank you very much.
Yes, we plan to use the "staggered approach". We used to plan the replicative design, but a large dropout was observed during our last bioequivalence study (crossover design but with long blood sampling interval) due to completely unrelated to the study reasons. Thus, the company decided to put on hold the replicative design given that a clinical center can accommodate only a bit more than 35 volunteers.
We are opting for the model III and will try to use the FDA requirements to justify the statistical model in the protocol. Bioequivalence studies done in accordance with international standards are relatively new for Belarus. As a result, experience, training, and lore are issues for major players (manufacturers, regulators, clinical investigators). We also cannot run studies outside the Eurasian Economic Union. Thus, from time to time our regulators have to rely on opinions of more experienced colleagues, mainly from EMA and FDA. If they see that something is acceptable in Europe or the USA, they usually give us a green light. That why we need papers or proper references.
Regards,
Mikalai.
Thank you very much.
Yes, we plan to use the "staggered approach". We used to plan the replicative design, but a large dropout was observed during our last bioequivalence study (crossover design but with long blood sampling interval) due to completely unrelated to the study reasons. Thus, the company decided to put on hold the replicative design given that a clinical center can accommodate only a bit more than 35 volunteers.
We are opting for the model III and will try to use the FDA requirements to justify the statistical model in the protocol. Bioequivalence studies done in accordance with international standards are relatively new for Belarus. As a result, experience, training, and lore are issues for major players (manufacturers, regulators, clinical investigators). We also cannot run studies outside the Eurasian Economic Union. Thus, from time to time our regulators have to rely on opinions of more experienced colleagues, mainly from EMA and FDA. If they see that something is acceptable in Europe or the USA, they usually give us a green light. That why we need papers or proper references.
Regards,
Mikalai.
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 GLs Mikalai 2018-01-04 10:43
- Belarus = member of the EEU Helmut 2018-01-04 13:08
- Belarus = member of the EEUMikalai 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