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dixit ★ India, 2009-09-02 09:52 (5732 d 05:04 ago) (edited on 2009-09-02 11:31) Posting: # 4140 Views: 5,291 |
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Dear all, we are going to conduct a study, in which many adverse events are observed with the study drug. So to minimise the AEs we are administering drug X just before 30 minutes of Study drug administration.. Now my question is How to maintain the water restriction 1 hour pre dose and 1 hour Post dose.. Please guide me with relevant literature Regards DIXIT  -- Edit: Category changed. [Jaime] |
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Helmut ★★★   Vienna, Austria, 2009-09-02 15:55 (5731 d 23:02 ago) @ dixit Posting: # 4142 Views: 4,032 |
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Dear Dixit! ❝ How to maintain the water restriction 1 hour pre dose and 1 hour Post dose.. This restriction is stated in some (not all!) general guidelines. As all guidelines, they may be inadequate for a given drug/regimen. See here. If in your specific situation something is justifiable based on clinical grounds, fine. The protocol has to pass the IEC/IRB and the competent authority anyhow. If they don’t like it, they will tell. ❝ Please guide me with relevant literature Examples are antidiabetics (where a dextrose solution is administered either together with the study drug or even every 15 minutes post dose). See this post. — Dif-tor heh smusma 🖖🏼 Довге життя Україна! ![[image]](https://static.bebac.at/pics/Blue_and_yellow_ribbon_UA.png) Helmut Schütz ![[image]](https://static.bebac.at/img/CC by.png) The quality of responses received is directly proportional to the quality of the question asked. 🚮 Science Quotes |
Ing. Helmut Schütz