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RegisterDosing fluid for BE study China [Regulatives / Guidelines]
posted by Helmut 
– Vienna, Austria, 2008-09-30 15:51 (6458 d 14:13 ago) – Posting: # 2447
Views: 3,490
Dear chak!
Wow, do you have an online reference (I could not find anthing on the English site and failed to navigate through the Chinese site by means of![[image]](img/uploaded/image219.png)
-translate as well).
If I remember it correctly, Andrew Sutton worked in the mid-1980s not only on the influence of different volumes, but also on temperatures of water on gastric emptying. Although somewhat anecdotal there’s a consensus that cold (let’s say ≤10 ℃) water may decrease gastric motility.
Most CROs administer drugs together with water of ambient (room) temperature. I would suspect that warm water may lead to nausea in some subjects.
❝ As per china guideline, for BE study…
Wow, do you have an online reference (I could not find anthing on the English site and failed to navigate through the Chinese site by means of
-translate as well).❝ … the dosing should be done with 200-250ml warm water. Now can anyone guide me what is the fact behind using warm water?
If I remember it correctly, Andrew Sutton worked in the mid-1980s not only on the influence of different volumes, but also on temperatures of water on gastric emptying. Although somewhat anecdotal there’s a consensus that cold (let’s say ≤10 ℃) water may decrease gastric motility.
❝ what should be the temp. of warm water?
Most CROs administer drugs together with water of ambient (room) temperature. I would suspect that warm water may lead to nausea in some subjects.
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Dif-tor heh smusma 🖖🏼 Довге життя Україна!
Helmut Schütz
The quality of responses received is directly proportional to the quality of the question asked. 🚮
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Complete thread:
- Dosing fluid for BE study China chak 2008-09-30 09:44 [Regulatives / Guidelines]
![[Mix]](https://static.bebac.at/img/mix.png "open in Mix view")
- Dosing fluid for BE study ChinaHelmut 2008-09-30 13:51
- Dosing fluid for BE study China chak 2008-09-30 15:10
- Dosing fluid for BE study China El_Guapo 2009-01-16 19:23
- Dosing fluid for BE study ChinaHelmut 2008-09-30 13:51
Ing. Helmut Schütz