Log in
RegisterRSABE: Statistics & Regulatory requirements [RSABE / ABEL]
I just want to know that for RSABE study in addition to having a point estimate in between 80-125, do we need to calculate the 90% CI limits as we do in ABE study? (Is there a regulatory requirement?)
Moreover in order to establish BE, the 95% upper confidence bound must be less than or equal to 0. How it is calculated based on the BE outcomes and in simple term what does it mean? i.e what it means if the value is less than or equal to 0 and greater than 0.
Regards,
Dhruv Shah
Moreover in order to establish BE, the 95% upper confidence bound must be less than or equal to 0. How it is calculated based on the BE outcomes and in simple term what does it mean? i.e what it means if the value is less than or equal to 0 and greater than 0.
Regards,
Dhruv Shah
Complete thread:
- RSABE: Statistics & Regulatory requirementsDhruv Shah 2015-09-28 11:08
![[Mix]](https://static.bebac.at/img/mix.png "open in Mix view")
- RSABE: Statistics & Regulatory requirements jag009 2015-10-01 13:57
- RSABE: Statistics & Regulatory requirements d_labes 2015-10-01 16:23
Ing. Helmut Schütz