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RegisterLow AUC after reference product [Study Assessment]
Hi Helmut,
If 5% GMR for ref is not mentioned in the Protocol isn't possible just to refer to EMA or other appropriate GL (depending on the jurisdiction)?
Have you ever seen lucky guys in EMA jurisdiction who stated in the protocol some additional reasons for exclusion (not mentioned in GL) after ending the bioanalytical part and successfully applied them in borderline case like that?
❝ Correct – if you didn’t state such a possible reason for exclusion it in the protocol.
If 5% GMR for ref is not mentioned in the Protocol isn't possible just to refer to EMA or other appropriate GL (depending on the jurisdiction)?
Have you ever seen lucky guys in EMA jurisdiction who stated in the protocol some additional reasons for exclusion (not mentioned in GL) after ending the bioanalytical part and successfully applied them in borderline case like that?
—
Kind regards,
Mittyri
Kind regards,
Mittyri
Complete thread:
- Outlier in BE ramgopi 2018-03-14 11:29 [Study Assessment]
![[Mix]](https://static.bebac.at/img/mix.png "open in Mix view")
- Low AUC after reference product Helmut 2018-03-14 16:38
- Low AUC after reference productmittyri 2018-03-15 10:56
- Outlier in BE ramgopi 2018-03-18 07:44
- Outlier in BE ElMaestro 2018-03-18 14:43
- Outlier in BE ramgopi 2018-03-19 10:55
- Outlier in BE ElMaestro 2018-03-18 14:43
- Low AUC after reference product Helmut 2018-03-14 16:38
Ing. Helmut Schütz