additional water to subject [Study Per­for­mance]

posted by Helmut Homepage – Vienna, Austria, 2013-06-25 17:56 (4397 d 20:38 ago) – Posting: # 10877
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Dear Dan & Suchit

❝ […] I see no reason why the subject should be so thirsty that he should drink an additional amount of any kind of beverage within 2 hours after administration.


Since Suchit wrote

❝ […] subject requesting for additional water to consume investigational product


I guess this was not a question of being thirsty. If the drug sticks to the esophagus it might play havoc to absorption. In such a case I would allow for some more water to make sure the drug reaches the stomach.

❝ If he does it is a protocol deviation which has to be recorded.


Agree.
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