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RegisterStatistically different or clinically different [General Statistics]
Hi all,
I have one study result with me of diuretic class drug. The study was refrence replicated study with N=50. The result obtained is given below
Cmax - 91.41(83.04 - 100.62), CV=34.25, Power=96.82
AUC(0 to t)- 90.14(85.78 - 94.72) , CV=17.31, Power=100.00
As we understand, in Nordic countries, it is a requirement that the interval cover 100% in order to obtain generic substitution. In view of this requirement and our study results what should be the possible justification we can present to the agency if query come.
I have one study result with me of diuretic class drug. The study was refrence replicated study with N=50. The result obtained is given below
Cmax - 91.41(83.04 - 100.62), CV=34.25, Power=96.82
AUC(0 to t)- 90.14(85.78 - 94.72) , CV=17.31, Power=100.00
As we understand, in Nordic countries, it is a requirement that the interval cover 100% in order to obtain generic substitution. In view of this requirement and our study results what should be the possible justification we can present to the agency if query come.
—
Kumar Naidu
Kumar Naidu
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 different Ohlbe 2008-09-06 16:43
- Statistically different or clinically different shri 2008-09-08 06:29
- Statistically different or clinically differentkumarnaidu 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 differentkumarnaidu 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 significance ElMaestro 2008-09-05 08:50
Ing. Helmut Schütz