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Dr pradip solanki ☆ India, 2012-09-01 14:01 (5048 d 09:44 ago) Posting: # 9137 Views: 6,562 |
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Is it acceptable to use Veg.Breakfast in USFDA Fed study with comparable volume,content and caloric requirement as per non veg breakfast suggested by USFDA |
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drgunasakaran1 ★★  2012-09-01 15:08 (5048 d 08:38 ago) @ Dr pradip solanki Posting: # 9138 Views: 5,794 |
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Dear Dr Pradip Solanki, Kindly follow the Forum’s Policy. See here ❝ Is it acceptable to use Veg.Breakfast in USFDA Fed study with comparable volume,content and caloric requirement as per non veg breakfast suggested by USFDA Yes. USFDA accepts vegetarian food menu as Fed Breakfast menu for FDA studies with comparable volume, content and caloric requirement. FDA states that Substitutions in this test meal can be made as long as the meal provides a similar amount of calories from protein, carbohydrate, and fat and has comparable meal volume and viscosity. — 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 |
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Helmut ★★★   Vienna, Austria, 2012-09-01 16:23 (5048 d 07:23 ago) @ drgunasakaran1 Posting: # 9139 Views: 5,698 |
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Dear S. Gunasakaran! ❝ […] comparable meal volume and viscosity. Out of curiosity: Which vegetable has a viscosity [sic] comparable to fried bacon? I’m always wondering whether FDA mistook in the guideline viscosity (of a solid?!) for texture and/or shear stress.  — 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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Dr pradip solanki ☆ India, 2012-11-01 09:49 (4987 d 12:56 ago) @ Helmut Posting: # 9490 Views: 5,276 |
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❝ ❝ […] comparable meal volume and viscosity. ❝ ❝ Out of curiosity: Which vegetable has a viscosity [sic] comparable to fried bacon? I’m always wondering whether FDA mistook in the guideline viscosity (of a solid?!) for texture and/or shear stress. How to measure viscosity of solid? or how we can compare viscocity of veg and non veg breakfast? FDA has to be clear regarding this issue, or has to change/remove the word "viscosity" from guideline. |
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Helmut ★★★ Vienna, Austria, 2012-11-01 15:34 (4987 d 07:11 ago) @ Dr pradip solanki Posting: # 9495 Views: 5,255 |
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Dear Pradip! ❝ ❝ […] Which vegetable has a viscosity [sic] comparable to fried bacon? I’m always wondering whether FDA mistook in the guideline viscosity (of a solid?!) for texture and/or shear stress. ❝ ❝ How to measure viscosity of solid? or how we can compare viscosity of veg and non veg breakfast? Did you notice the irony-smiley in my post? Viscosity is not a physical property of solids – therefore nothing to compare. See this post for some background information. ❝ FDA has to be clear regarding this issue, or has to change/remove the word "viscosity" from guideline. Send FDA a letter asking for clarification. Once you get a response please enlighten us. Suds’ post below is discouraging. BTW, in this presentation from 2008 FDA stated:
Palamakula A, Bough K, Conner D, Kim S, and B Davit — Dif-tor heh smusma 🖖🏼 Довге життя Україна! Helmut Schütz The quality of responses received is directly proportional to the quality of the question asked. 🚮 Science Quotes |
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suds4u ☆ India, 2012-09-03 10:26 (5046 d 13:19 ago) @ Dr pradip solanki Posting: # 9141 Views: 5,819 |
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Dear Dr. We have had issues with the Indian Breakfast[VEG] provided to one of the fed studies that was submitted to US FDA. Though we had taken care of all the elements, it took a lot of correspondances to clear the query posted by FDA authorities. The study / submission may still be inspected for that issue alone. Better to stick to the guideline menu. Regards Suds |
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Dr RCG ☆ 2012-11-20 06:37 (4968 d 16:08 ago) @ suds4u Posting: # 9554 Views: 4,911 |
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Dear All: I my experience with USFDA, I totally agree with "Suds". USFDA have lots of issues with veg breakfast and also it’s very difficult to convey them. You will expect lot of question/query/correspondence from USFDA if you use veg breakfast. Its always better to stick with guideline menu…  |
Ing. Helmut Schütz