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sam ★ India, 2012-10-10 12:53 (5010 d 10:16 ago) Posting: # 9370 Views: 3,582 |
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Dear All I have seen a word in the statement given by the Guidance for Industry (Food-Effect Bioavailability and Fed Bioequivalence Studies). The sentence is “An example test meal would be two eggs fried in butter, two strips of bacon, two slices of toast with butter, four ounces of hash brown potatoes and eight ounces of whole milk. 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.” In this particular sentence there is word of meal viscosity. So please let me know if any specific recommendation related to the viscosity of food is there or it’s exact meaning is somewhat different from the viscosity. Hope for your positive reply. Regards Sam Edit: Guidance linked. [Helmut] |
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Helmut ★★★ ![]() Vienna, Austria, 2012-10-10 15:38 (5010 d 07:31 ago) @ sam Posting: # 9375 Views: 3,134 |
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Dear Sam, good point! Search also the forum, see especially this post.Viscosity appeared first in the Oct 2001 draft of the guidance (not stated in the Oct 1997 draft)… ❝ So please let me know if any specific recommendation related to the viscosity of food is there or it’s exact meaning is somewhat different from the viscosity. Of course viscosity of fried bacon is perfect nonsense. I guess (!) FDA targets texture, fiber content, whatever – which might influence gastric transit time. I think that they don’t want us to serve some kind of astronaut food (= pulp in sachets). On the other hand I have heard about BE studies in oncology (patients can’t eat such a BF), where exactly such a substitute was used. — 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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ElMaestro ★★★ Denmark, 2012-10-10 16:25 (5010 d 06:44 ago) @ Helmut Posting: # 9377 Views: 2,981 |
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Dear Helmut, re. your viscosity concern may I suggest that you consider a bacon smoothie? I am sure we can substitute berries for eggs, cocoa powder for hash browns, and so forth. Delicious! All worries gone. ![]() — Pass or fail! ElMaestro |

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