Bioequivalence and Bioavailability Forum • FDA: Test Meal

krish
☆

India,
2014-09-16 09:29
(3502 d 16:45 ago)

Posting: # 13513
Views: 1,740

FDA: Test Meal [Regulatives / Guidelines]

Dear All,

As per FDA's draft guidance on Bioequivalence Studies with Pharmacokinetic Endpoints for Drugs Submitted Under an ANDA the following is mentioned.

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 (e.g., beef or chicken instead of bacon) can be made as long as the meal provides a similar amount of calories from protein, carbohydrate, and fat and has comparable meal volume, density, and viscosity.

Can any one please let me know in detail about volume, density, and viscosity of food and how to quantify these parameters.

Regards,

KRISH :-)

Edit: Guidance linked. [Helmut]

Helmut
★★★

Vienna, Austria,
2014-09-16 11:03
(3502 d 15:11 ago)

@ krish
Posting: # 13516
Views: 1,410

ρ = m/V

Post reply

Hi Krish,

yes, that’s weird; although only density was added to the requirements of the Guidance Food-Effect Bioavailability and Fed Bioequivalence (2002). :hungry:

I wonder which egg-head introduced this (and why).

❝ Can any one please let me know in detail about volume, density, and viscosity of food and how to quantify these parameters.

Counter-question: How did you quantify volume and – especially – viscosity in the last twelve years? Once you are able to measure the meal’s volume, weigh it and calculate ρ = m/V.
BTW, please let us know how you determined the volume of an inhomogenous material containing voids. That’s important.

—
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Helmut Schütz

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