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Hi Shri,
in general, when 100 (1.00) is not a part of your CI it is not a problem.
You have shown that the two products are not identical in terms of AUC or Cmax, but still they may be considered bioequivalent, provided of course that the CI is contained within the usual boundaries.
Often this is just a symptom of overpowering (the variability was lower than expected, more completers than expected or similar). This just makes the data material better, certainly not worse. Otherwise we end up in situations where the company 'should have included fewer subjects' and got a wider CI.
Denmark at some point signaled that they wouldnot accept BE if 100 (1.00) was not part of the CI. May the powers that be forgive their sins and have mercy upon them.
EM.
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Edit: Full quote removed. Please see this post! [Jaime]
in general, when 100 (1.00) is not a part of your CI it is not a problem.
You have shown that the two products are not identical in terms of AUC or Cmax, but still they may be considered bioequivalent, provided of course that the CI is contained within the usual boundaries.
Often this is just a symptom of overpowering (the variability was lower than expected, more completers than expected or similar). This just makes the data material better, certainly not worse. Otherwise we end up in situations where the company 'should have included fewer subjects' and got a wider CI.
Denmark at some point signaled that they wouldnot accept BE if 100 (1.00) was not part of the CI. May the powers that be forgive their sins and have mercy upon them.
EM.
--
Edit: Full quote removed. Please see this post! [Jaime]
Complete thread:
- Treat significance shri 2008-09-05 07:42
![[Mix]](https://static.bebac.at/img/mix.png "open in Mix view")
- Treat significanceElMaestro 2008-09-05 08:50
- Denmark Ohlbe 2008-09-05 10:27
- Denmark ElMaestro 2008-09-05 12:02
- Denmark shri 2008-09-06 10:25
- Statistically different or clinically different Ohlbe 2008-09-06 16:43
- Statistically different or clinically different shri 2008-09-08 06:29
- Statistically different or clinically different kumarnaidu 2014-03-14 06:54
- Statistically different or clinically different ElMaestro 2014-03-14 07:10
- Statistically different or clinically different kumarnaidu 2014-03-14 12:36
- Post hoc power #666 Helmut 2014-03-14 13:31
- Post hoc power - power of which test? d_labes 2014-03-14 13:53
- Post hoc power - power of which test? kumarnaidu 2014-03-15 10:56
- Statistically different or clinically different ElMaestro 2014-03-14 07:10
- Statistically different or clinically different kumarnaidu 2014-03-14 06:54
- Statistically different or clinically different shri 2008-09-08 06:29
- Statistically different or clinically different Ohlbe 2008-09-06 16:43
- Denmark Ohlbe 2008-09-05 10:27
- Treat significanceElMaestro 2008-09-05 08:50
Ing. Helmut Schütz