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scorp2011 ☆ India, 2012-10-30 11:14 (4985 d 13:48 ago) Posting: # 9483 Views: 5,649 |
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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] |
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drgunasakaran1 ★★  2012-11-01 11:11 (4983 d 13:51 ago) @ scorp2011 Posting: # 9491 Views: 4,386 |
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Dear Mr Scorp, ❝ 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 |
Ing. Helmut Schütz