Fed breakfast-USFDA [Study Per­for­mance]

posted by sumatha balusu – 2008-11-27 10:48 (6067 d 03:07 ago) – Posting: # 2813
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(edited on 2008-11-28 08:45)

❝ 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. How to address this while filing a protocol deviation.


Hi,
You need to consider both the guidelines and protocol before addressing such a deviation, since you need to give a justification for the same.

As per the guidelines "high-calorie (approximately 800 to 1000 calories) meal is recommended as a test meal for food-effect BA and fed BE studies but all depends on what has been mentioned in the protocol".

Since there is only one volunteer has consumed less calories we can address the deviation along with the justification on what situation he didnot consume.

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