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RegisterEMA: all effects fixed - Method A! [RSABE / ABEL]
Dear RK!
Since we are talking about EMA submission: none of them.
As Helmut already pointed out the EMA prefers what they call 'Method A' i.e. the
Talking about the scientific rationale behind this preference is impossible since it seems a pure 'political' decision
.
BTW: In case of no missings in your dataset 'Method A' and 'Method B' will give practically the same results.
❝ I have compared the methods B and C,
❝
❝ The results are,
❝
❝ Ratio and 90% CI,
❝
❝ Method B:92.21(80.81,105.21)
❝ Method C:92.41(82.57,103.42)
❝ which one is correct???
Since we are talking about EMA submission: none of them.
As Helmut already pointed out the EMA prefers what they call 'Method A' i.e. the
Proc GLM code given in the EMA Q&A-document. The code behind 'Method A' is the same as is usually employed for a classical 2x2x2 crossover.Talking about the scientific rationale behind this preference is impossible since it seems a pure 'political' decision
.BTW: In case of no missings in your dataset 'Method A' and 'Method B' will give practically the same results.
—
Regards,
Detlew
Regards,
Detlew
Complete thread:
- Clarification on model statement in EMEA submission RK 2013-10-08 13:39
![[Mix]](https://static.bebac.at/img/mix.png "open in Mix view")
- EMA: all effects fixed Helmut 2013-10-08 14:08
- EMA: all effects fixed RK 2013-10-09 06:32
- EMA: all effects fixed - Method A!d_labes 2013-10-09 08:30
- EMA: Method C “incompatible with CHMP GL” Helmut 2013-10-09 14:50
- EMA: Method C “incompatible with CHMP GL” RK 2013-10-10 06:01
- EMA: all effects fixed RK 2013-10-09 06:32
- EMA: all effects fixed Helmut 2013-10-08 14:08
Ing. Helmut Schütz