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Dear Helmut and all,
If one test and two references of different regions are tested in a bioequivalence study, is it necessary a α adjustment?
In my case, we want to demonstrate if the test product is bioequivalent to R1 (European product reference) or if test product is bioequivalent to R2 (Reference product in the United Kingdom).
If I have not misunderstood, in this case, alpha should be penalized, even if they are from different regions and to market in different regions because of the word "OR"?
Is there a way to not penalize alpha? If the "O" is changed to "AND"? Executing two different clinical trials (one for Europe and one for the UK)?
Best regards,
If one test and two references of different regions are tested in a bioequivalence study, is it necessary a α adjustment?
In my case, we want to demonstrate if the test product is bioequivalent to R1 (European product reference) or if test product is bioequivalent to R2 (Reference product in the United Kingdom).
If I have not misunderstood, in this case, alpha should be penalized, even if they are from different regions and to market in different regions because of the word "OR"?
Is there a way to not penalize alpha? If the "O" is changed to "AND"? Executing two different clinical trials (one for Europe and one for the UK)?
Best regards,
Complete thread:
- Decision of confidence interval of three period BE study libaiyi 2018-06-26 12:00
![[Mix]](https://static.bebac.at/img/mix.png "open in Mix view")
- Two tests and one reference Helmut 2018-06-26 13:13
- Two tests and one referenceBrus 2020-08-31 09:58
- Two tests and one reference ElMaestro 2020-08-31 10:23
- Two regions: No α adjustment Helmut 2020-08-31 10:26
- Two regions: No α adjustment Brus 2020-08-31 11:09
- Two regions: different populations Helmut 2020-08-31 11:26
- Two regions: No α adjustment Brus 2020-08-31 11:09
- Two tests and one referenceBrus 2020-08-31 09:58
- Decision of confidence interval of three period BE study ElMaestro 2018-06-26 22:20
- Any of two tests and one reference Helmut 2018-06-27 00:33
- Any of two tests and one reference libaiyi 2018-06-27 08:25
- Hey wait a moment.... ElMaestro 2018-06-27 08:29
- Hey wait a moment.... Helmut 2018-06-27 11:45
- Pilot or pivotal ? Ohlbe 2018-06-27 12:14
- Pilot or pivotal ? ElMaestro 2018-06-27 13:01
- Pilot or pivotal ? Ohlbe 2018-06-27 14:13
- Pilot or pivotal ? ElMaestro 2018-06-27 14:48
- Pilot or pivotal ? Ohlbe 2018-06-27 15:43
- Pilot or pivotal ? ElMaestro 2018-06-27 22:13
- Pilot or pivotal ? Ohlbe 2018-06-27 15:43
- Pilot or pivotal ? ElMaestro 2018-06-27 14:48
- Pilot or pivotal ? Ohlbe 2018-06-27 14:13
- Pilot or pivotal ? jag009 2018-06-29 20:53
- Pilot or pivotal ? ElMaestro 2018-06-29 22:11
- Pilot or pivotal ? jag009 2018-07-03 17:38
- Pilot or pivotal ? ElMaestro 2018-06-29 22:11
- Pilot or pivotal ? ElMaestro 2018-06-27 13:01
- Hey, hey wait another moment.... d_labes 2018-06-28 19:48
- Hey, hey wait another moment.... Helmut 2018-07-03 17:22
- Old belives die hard d_labes 2018-07-04 13:28
- Hey, hey wait another moment.... Helmut 2018-07-03 17:22
- Pilot or pivotal ? Ohlbe 2018-06-27 12:14
- Hey wait a moment.... Helmut 2018-06-27 11:45
- Any of two tests and one reference Helmut 2018-06-27 00:33
- Two tests and one reference Helmut 2018-06-26 13:13
Ing. Helmut Schütz