Bioequivalence and Bioavailability Forum

Hi,
I was planning to reduce the calorie of high fat breakfast for fed BE studies keeping the total calorie within recomended range of USFDA.

As per the present food effect BE guideline (USFDA), the recommendation are as below,

1. Food-effect BA and fed BE studies be conducted using meal conditions that are expected to provide the greatest effects on GI physiology so that systemic drug availability is maximally affected.
   
2. A high-fat (approximately 50 percent of total caloric content of the meal)
   
3. High-calorie (approximately 800 to 1000 calories) meal is recommended as a test meal for food-effect BA and fed BE studies.
   
4. This test meal should derive approximately 150, 250, and 500-600 calories from protein, carbohydrate, and fat, respectively.

With the above instructions we are getting menu as below,

1. Protein 150 (16.67%), Carbohydrate 250 (27.78%), fat 500 (55.56%). Total 900 cal
   
2. Protein 150 (15%), Carbohydrate 250 (25%), fat 600 (60%). Total 1000 cal

Calorie from Protein ranges from 15% to 16.67%
Calorie from Carbohydrate rangees from 25% to 27.78%
Calorie from fat ranges from 55.56% to 60%

Considering the above conditions I am requesting you to guide me for the following doubts.

1. How much variation (%) to be considered as approximate. Can we go below 50% of total calorie derived from fat?
   
2. Will it be acceptable if we use a high fat high calorie breakfast menu of 800 cal as per the distribution below?

Calorie from Protein 150 (12.5% to 18.75%)
Calorie from Carbohydrate (200 to 250) (25% to 31.25%)
Calorie from fat (400 to 450) (50% to 62.5%)
Estimated Total calorie 800 (100%)

Kindly give your opinion.

Thanks and Regards,
Dr. Naba