sam
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India,
2012-10-10 12:53
(5010 d 10:16 ago)

Posting: # 9370
Views: 3,582
 

 food viscosity requirement for fed state BE study as per US [Regulatives / Guidelines]

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]
Helmut
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Vienna, Austria,
2012-10-10 15:38
(5010 d 07:31 ago)

@ sam
Posting: # 9375
Views: 3,134
 

 Viscosity?!

Dear Sam,

good point! :-D [image] 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.

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ElMaestro
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Denmark,
2012-10-10 16:25
(5010 d 06:44 ago)

@ Helmut
Posting: # 9377
Views: 2,981
 

 No problem!

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. :pirate:

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