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RegisterBE analysis – sensitivity analysis [Regulatives / Guidelines]
Hi,
As per EMA guidance document for a 2x2 Cross-over design, BE analysis should be performed on complete cases (and thus using seq, period, trt, and subject within seq as fixed effects).
Since other H-A guidelines don't clearly specify the same, would it be recommanded to have a sensitivity analysis based on all data (complete and incomplete cases) with a random effect model?
The concern might be if your initial analysis shows BE but not the sensitivity analysis....
As per EMA guidance document for a 2x2 Cross-over design, BE analysis should be performed on complete cases (and thus using seq, period, trt, and subject within seq as fixed effects).
Since other H-A guidelines don't clearly specify the same, would it be recommanded to have a sensitivity analysis based on all data (complete and incomplete cases) with a random effect model?
The concern might be if your initial analysis shows BE but not the sensitivity analysis....
Complete thread:
- BE analysis – sensitivity analysismanu126 2012-09-14 08:23
![[Mix]](https://static.bebac.at/img/mix.png "open in Mix view")
- BE analysis – sensitivity analysis ElMaestro 2012-09-14 09:14
Ing. Helmut Schütz