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RegisterRestriction on widened limit -AUC of HVD [RSABE / ABEL]
Hi all
Can any one through some light on why EMA do not allow widening of CI limits for AUC of HVDs? Whereas RSABE is applicable for AUC as well by USFDA.
rgds/Ashokraj
Can any one through some light on why EMA do not allow widening of CI limits for AUC of HVDs? Whereas RSABE is applicable for AUC as well by USFDA.
rgds/Ashokraj
Complete thread:
- Restriction on widened limit -AUC of HVDashokraj 2015-07-22 14:26
![[Mix]](https://static.bebac.at/img/mix.png "open in Mix view")
- No scaled ABE for AUC d_labes 2015-07-22 16:03
- History lesson Helmut 2015-07-22 16:26
Ing. Helmut Schütz