## calory calculation [Design Issues]

❝ Is there any standard book or reference for calory calculation specially for indian healthy volunteers involved in fast/fed studies?

I am not sure whether I do understand your question
Do you want to calculate the energy content (and calories from carbohydrates, fat, protein)?
In such a case you just have to define your preferred test meal and go for one of the many online calculators on the web:

❝ Does our standards of approximate calory calculation correlate with the

❝ ICH countries? If no, how we can overcome this problem?

Again I am a little confused.
Calory calculation is always approximate. BA/BE is not covered in any ICH Guideline, and test meals applied in the ICH-regions and others are also quite different:

USA FDA (166kB PDF) (http://www.fda.gov/cder/guidance/5194fnl.pdf)

A high-fat (approximately 50 percent of total caloric content of the meal) and high-calorie (approximately 800 to 1000 calories) meal is recommended as a test meal for food-effect BA and fed BE studies. This test meal should derive approximately 150, 250, and 500-600 calories from protein, carbohydrate, and fat, respectively. [Footnote:] 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. If the caloric breakdown of the meal is significantly different from the one described above, the sponsor should provide a scientific rationale for this difference.

Canada HPFB (25kB PDF)

The test meal employed in comparative BA studies conducted in the fed state for purposes of BE assessment should be a representative meal in which sufficient food is given to allow potential perturbation of systemic BA of the drug from the drug product. The sponsor should justify the choice of meal and relate the specific components and timing of food administration.
An example of a test meal that is expected to promote the greatest perturbation in gastrointestinal physiology so that systemic drug BA is maximally affected would be the following breakfast: 2 eggs fried in butter, 2 strips of bacon, 2 slices of toast with butter, 120 gm of hash browns and 240 ml of whole milk. Sponsors must be able to justify the choice of meal in a fed BE study and relate the specific components and timing of food administration.

Japan NIH (60kB PDF)

There are two different meals suggested in the guideline:
[…] a low fat diet of 700 kcal or less containing not more than 20 % by energy of the lipid.
[…] a high fat diet of 900 kcal or more containing 35% lipid content.

New Zealand MEDSAFE (5.1MB DOC)

The meal should contain approximately 30-40g of fat as this is likely to cause maximum perturbation to the release and absorption of the medicine.

PAHO (868kB PDF)

A high-fat (approximately 50 percent of total caloric content of the meal) and high-calorie (approximately 800 to 1000 calories) meal is recommended as a test meal for food-effect BA and fed BE studies. This test meal should derive approximately 150, 250, and 500-600 calories from protein, carbohydrate, and fat, respectively.

India CDSCO (107kB PDF)

Studies in the fed state require the consumption of a high-fat breakfast before dosing. Such a breakfast must be designed to provide 950 to 1000 KCals. At least 50% of these calories must come from fat, 15 to 20% from proteins and the rest from carbohydrates. The vast ethnic and cultural variations of the Indian subcontinent preclude the recommendation of any single standard high fat breakfast. Protocol should specify the suitable and appropriate diet.

European Union EMEA (90kB PDF)
Since 1999 still Draft 15

The optimal experimental conditions to produce a food effect include the ingestion of a predefined high fat meal immediately before dosing.

In my experience European CROs often tried to match FDA's standard meal by means of more 'European' ingredients. By this it was possible to substitute FDA's standard meal while following EU guidelines (predefined high fat).
In the last revision (Dec 2002) of the guideline FDA added two words in the footnote stating the composition of a substitute meal, namely ‘… and viscosity’.
It was possible to compose an alternative meal with ‘similar amount of calories from protein, carbohydrate, and fat and … comparable meal volume’ from local ingredients; any attempt to match the viscosity of ‘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’ simply failed…
BTW: what's the viscosity of a solid?

Since that time poor European volunteers are struggling to get the ‘American Breakfast’ down their throats…

Edit: Link corrected for FDA’s new site. [Helmut]

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Helmut Schütz

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