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RegisterFed breakfast-USFDA [Study Performance]
Dear members,
I would like to know what could be the impact on a Fed study when one volunteer has consumed 200 Kcalories less than the actual consumption of 930 Kcal (as per Protocol). Knowing this fact also the volunteer was continued for the study. The drug under study is a highly variable drug (a proton pump inhibitor class).
How to address this situation when filing a protocol deviation.
In anticipation of your valuable comment.
Thanks
Chirag khatri
I would like to know what could be the impact on a Fed study when one volunteer has consumed 200 Kcalories less than the actual consumption of 930 Kcal (as per Protocol). Knowing this fact also the volunteer was continued for the study. The drug under study is a highly variable drug (a proton pump inhibitor class).
How to address this situation when filing a protocol deviation.
In anticipation of your valuable comment.
Thanks
Chirag khatri
Complete thread:
- Fed breakfast-USFDAchiragkhatri 2008-11-21 13:52
![[Mix]](https://static.bebac.at/img/mix.png "open in Mix view")
- Fed breakfast-USFDA Sasi 2008-11-22 06:41
- Fed breakfast-USFDA sumatha balusu 2008-11-27 09:48
- Fed breakfast-USFDA chidambarajoshi 2008-11-27 10:42
- Fed breakfast-USFDA sumatha balusu 2008-11-27 12:32
- Fed breakfast-USFDA chidambarajoshi 2008-11-27 12:41
- Fed breakfast-USFDA sumatha balusu 2008-11-28 07:06
- Fed breakfast-USFDA chidambarajoshi 2008-11-28 12:56
- Fed breakfast-USFDA sumatha balusu 2008-12-09 08:39
- Fed breakfast-USFDA chidambarajoshi 2008-11-28 12:56
- Fed breakfast-USFDA sumatha balusu 2008-11-28 07:06
- Fed breakfast-USFDA chidambarajoshi 2008-11-27 12:41
- Fed breakfast-USFDA sumatha balusu 2008-11-27 12:32
- Fed breakfast-USFDA chidambarajoshi 2008-11-27 10:42
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