Bioequivalence and Bioavailability Forum

Dear Mr.Brijesh,

The Fed breakfast caloric requirements is not different for Oncology BE fed studies. The 50% of the total 800 - 1000 calorie requirement for Fed breakfast should be available from Fat.

However, the Fed breakfast menu can be changed in such a way so that cancer patients can able to consume them fully without any difficulty.

The fed breakfast may be a vegetarian or non-vegetarian menu.

An example test meal as suggested by FDA is 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. But, FDA itself states that 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.

You need to provide the caloric breakdown of the test meal in the clinical study report.