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RegisterOnly fed study [Design Issues]
Hi Helmut!
The reasoning behind is that although you write something in the SPC, there is no guarantee, that patients act accordingly, i.e. swallow your drug together with food. Maybe they 'know' that any drug acts 'faster'/'better' if adminstered on an empty stomach, or they don't even read the SPC.
Yes, but: see above
Again yes, but: I've heard of an application where the Dutch regulators wanted to see a fasting study - after the submitted fed study (which showed BE).
Regulators have all post approval data of the inovator's product on file; maybe that's the reason.
The reasoning behind is that although you write something in the SPC, there is no guarantee, that patients act accordingly, i.e. swallow your drug together with food. Maybe they 'know' that any drug acts 'faster'/'better' if adminstered on an empty stomach, or they don't even read the SPC.
❝ Anyhow, if the food effect documented in the reference's SmPC is
❝ safety-related (i.e., AEs due to GI-disturbances), you may start an
❝ argument.
Yes, but: see above
❝ Remark: in such a case European Guidelines call only for a fed
❝ study.
Again yes, but: I've heard of an application where the Dutch regulators wanted to see a fasting study - after the submitted fed study (which showed BE).
Regulators have all post approval data of the inovator's product on file; maybe that's the reason.
—
Regards, Jaime
Regards, Jaime
Complete thread:
- Only fed study roody 2005-10-04 19:10 [Design Issues]
![[Mix]](https://static.bebac.at/img/mix.png "open in Mix view")
- Only fed study Helmut 2005-10-04 19:45
- Only fed studyJaime_R 2005-10-04 20:42
- Only fed study Helmut 2005-10-04 19:45
Ing. Helmut Schütz