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RegisterSignificant differences in AEs [General Statistics]
Dear Dr_Dan
Sorry to hear this.
If the CIs show BE and the assessor can raise a PSRtPH on basis of count data, then the BE guideline apparently needs to be re-written as the traditional metrics do not assure BE for drug products like yours.
Less clear of course if your CI goes from 1.18-1.24 etc, when the assessor can definitely argue the exposure is higher. But if the CI spans over 1.0 this should -at least in theory- be a piece of cake.
Sorry to hear this.
If the CIs show BE and the assessor can raise a PSRtPH on basis of count data, then the BE guideline apparently needs to be re-written as the traditional metrics do not assure BE for drug products like yours.
Less clear of course if your CI goes from 1.18-1.24 etc, when the assessor can definitely argue the exposure is higher. But if the CI spans over 1.0 this should -at least in theory- be a piece of cake.
—
Pass or fail!
ElMaestro
Pass or fail!
ElMaestro
Complete thread:
- Adverse events Dr_Dan 2011-09-01 11:27
![[Mix]](https://static.bebac.at/img/mix.png "open in Mix view")
- Significant differences in AEs Helmut 2011-09-01 12:18
- Significant differences in AEs Dr_Dan 2011-09-01 15:44
- Significant differences in AEsElMaestro 2011-09-01 13:40
- Adverse events ElMaestro 2011-09-01 18:12
- Adverse events martin 2011-09-02 11:02
- Significant differences in AEs Helmut 2011-09-01 12:18
Ing. Helmut Schütz