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Dear Shri,
If you have a significant treatment effect, it just means that the test product and the reference product are statistically different. If the CI lies below 100, this means that the bioavailability of the test product is statistically lower than the reference product.
Statistically different doesn't mean that the difference has any clinical relevance, I mean that the difference may not have any impact on the patients taking the drug. That's why 90 % CI are calculated, and we are not just testing for treatment effect in the ANOVA. As long as your 90 % CI lies within the acceptance limits (usually 80-125), the products are still considered bioequivalent.
Regards
Ohlbe
If you have a significant treatment effect, it just means that the test product and the reference product are statistically different. If the CI lies below 100, this means that the bioavailability of the test product is statistically lower than the reference product.
Statistically different doesn't mean that the difference has any clinical relevance, I mean that the difference may not have any impact on the patients taking the drug. That's why 90 % CI are calculated, and we are not just testing for treatment effect in the ANOVA. As long as your 90 % CI lies within the acceptance limits (usually 80-125), the products are still considered bioequivalent.
Regards
Ohlbe
Complete thread:
- Treat significance shri 2008-09-05 07:42
![[Mix]](https://static.bebac.at/img/mix.png "open in Mix view")
- Treat significance ElMaestro 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 differentOhlbe 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 differentOhlbe 2008-09-06 16:43
- Denmark Ohlbe 2008-09-05 10:27
- Treat significance ElMaestro 2008-09-05 08:50
Ing. Helmut Schütz