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RegisterDeviation in predose fasting duration of 10 hours [Study Assessment]
Dear All,
In one of our four period BE study, during admission for Period - 2, four subjects were checked-in late and therefore maintaining fasting duration of 10 hours predose (as specified in the protocol) was an issue. In order to maintain the predose fasting duration, these subjects were dosed half an hour later in comparison to the dosing in Period - 1. But the post dose blood samples in period 2 were collected as per the original schedule.
Please clarify if there is any regulatory issues with the approach.
Thanks
Edit: Category changed. [Helmut]
In one of our four period BE study, during admission for Period - 2, four subjects were checked-in late and therefore maintaining fasting duration of 10 hours predose (as specified in the protocol) was an issue. In order to maintain the predose fasting duration, these subjects were dosed half an hour later in comparison to the dosing in Period - 1. But the post dose blood samples in period 2 were collected as per the original schedule.
Please clarify if there is any regulatory issues with the approach.
Thanks
Edit: Category changed. [Helmut]
Complete thread:
- Deviation in predose fasting duration of 10 hoursscorp2011 2012-10-30 10:14
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- Deviation in predose fasting duration of 10 hours drgunasakaran1 2012-11-01 10:11
Ing. Helmut Schütz