Log in
RegisterTwo tests and one reference [General Statistics]
Hi Brus,
» 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)?
Here's a different way to look at it:
Can the same patient(s) be affected by your two tests? If yes, it is safer to use correction. If no, no correction should be necessary.
» 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)?
Here's a different way to look at it:
Can the same patient(s) be affected by your two tests? If yes, it is safer to use correction. If no, no correction should be necessary.
—
Pass or fail!
ElMaestro
Pass or fail!
ElMaestro
Complete thread:
- Decision of confidence interval of three period BE study libaiyi 2018-06-26 12:00 [General Statistics]
![[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 reference Brus 2020-08-31 09:58
- Two tests and one referenceElMaestro 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 reference Brus 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