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chak ☆ 2008-09-30 11:44 (6458 d 16:41 ago) Posting: # 2442 Views: 3,790 |
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Hi all, As per china guideline, for BE study the dosing should be done with 200-250ml warm water. Now can anyone guide me what is the fact behind using warm water? what should be the temp. of warm water? regards chak |
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Helmut ★★★   Vienna, Austria, 2008-09-30 15:51 (6458 d 12:34 ago) @ chak Posting: # 2447 Views: 3,490 |
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Dear chak! ❝ 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 ![[image]](img/uploaded/image219.png) -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. — 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 |
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chak ☆ 2008-09-30 17:10 (6458 d 11:15 ago) @ Helmut Posting: # 2450 Views: 3,197 |
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Dear helmut, Thanks for sharing this information. I guess using water of ambient (room) temperature for dosing will do for BE study for china. Hope i am not overconfident. regards chak Edit: Full quote removed. Please see this post! [Jaime] |
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El_Guapo ☆ New Jersey, 2009-01-16 20:23 (6350 d 07:02 ago) @ Helmut Posting: # 3051 Views: 3,143 |
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Hi All, First time poster here so I hope it's a good one. I found a link for "Good Clinical Practice for Proprietary Chinese Medicines" http://www.cmchk.org.hk/pcm/pdf/test_e.pdf Couldn't find anything for BE/BA studies though. If anyone has info on this please let me know. I am looking for Guidances from China regarding BE/BA studies. Where exactly did you find the info regarding the 200-250 mL of warm water? That sounds like a document I need to read! Edit: Full quote removed. Please see this post! Remark: The linked document refers to Hong Kong. [Helmut] — R.W., BS, RAC (US) QA/RA Consultant |
Ing. Helmut Schütz