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Dear ElMaestro,
This is quite unclear to me ! The title of the web page only refers to substitution. But in the first paragraph it says:
The requirements apply to both authorisation of generic medicinal products and the subsequent labelling with regard to generic substitution on the Danish market.
Then you have a table with acceptance limits for 90 % CI for marketing authorisation and for substitution, where the limits for marketing authorisation are kept to 80-125 for all drugs except immunosuppressives, and are set to 90-111 for a number of drugs for substitution. But this criterion of the 90 % CI including 100 is not mentioned in the table.
If somebody has an experience with Denmark, or has time to call the contact person mentioned at the bottom of the web page, please let us know the outcome !
Regards
Ohlbe
❝ Do they apply these requirements solely in relation to substitution or do the requirements apply to approval of generics generally?
This is quite unclear to me ! The title of the web page only refers to substitution. But in the first paragraph it says:
The requirements apply to both authorisation of generic medicinal products and the subsequent labelling with regard to generic substitution on the Danish market.
Then you have a table with acceptance limits for 90 % CI for marketing authorisation and for substitution, where the limits for marketing authorisation are kept to 80-125 for all drugs except immunosuppressives, and are set to 90-111 for a number of drugs for substitution. But this criterion of the 90 % CI including 100 is not mentioned in the table.
If somebody has an experience with Denmark, or has time to call the contact person mentioned at the bottom of the web page, please let us know the outcome !
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
- DenmarkOhlbe 2008-09-05 12:31
- Denmark ElMaestro 2008-09-05 13:03
- DenmarkOhlbe 2008-09-05 12:31
- 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 ElMaestro 2008-09-05 12:02
- Denmark Ohlbe 2008-09-05 10:27
- Treat significance ElMaestro 2008-09-05 08:50
Ing. Helmut Schütz