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RegisterDeviation in predose fasting duration of 10 hours [Study Assessment]
Dear Mr Scorp,
The above deviation will be accepted by the Regulatory agency, if you file the appropriate protocol deviation form for the late check in and the corresponding late check out.
❝ 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.
The above deviation will be accepted by the Regulatory agency, if you file the appropriate protocol deviation form for the late check in and the corresponding late check out.
—
Dr Gunasakaran Sambandan MD
Disclaimer: The replies/posts are my personal opinions, and they do not represent my company's views on the same. LinkedIn
Dr Gunasakaran Sambandan MD
Disclaimer: The replies/posts are my personal opinions, and they do not represent my company's views on the same. LinkedIn
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- Deviation in predose fasting duration of 10 hours scorp2011 2012-10-30 10:14
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- Deviation in predose fasting duration of 10 hoursdrgunasakaran1 2012-11-01 10:11
Ing. Helmut Schütz