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Dear all.
What is the minimum K.Calories (High Fat High Calorie Breakfast) an
subject has to consume in a BA/BE Fed study,
Is there any guidelines suggesting the same.
Regards,
Dr.Sridhar
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Dear all.
What is the minimum K.Calories (High Fat High Calorie Breakfast) an
subject has to consume in a BA/BE Fed study,
Is there any guidelines suggesting the same.
Regards,
Dr.Sridhar
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Dr. Sridhar,
FDA food effect guideline states that the subjects have to consume a
test meal of approximately 800-1000 Kcal. I presume your question
stems out from a situation where a subject is not able to consume the
entire meal. There arent clear specifications in the guidance of how
such a practical situation has to be dealt with. Its always a good
practice to document and decide on a case to case basis (keeping in
mind the objective of the study).
I guess this was not what you were expecting.
Ganesh Mugundu
Web page: www.geocities.com/ganaish
--
Ganesh Mugundu
Web page: www.geocities.com/ganaish
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Dr.Sridhar,
A guidance for industry titled "Food-Effect Bioavailability and Fed
Bioequivalence Studies" is available on the FDA website.
Given below are the details mentioned in the guidance:
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.The
caloric breakdown of the test meal should be provided in the study
report. 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. In NDAs, it is recognized
that a sponsor can choose to conduct food-effect BA studies using
meals with different combinations of fats, carbohydrates, and
proteins for exploratory or label purposes. However, one of the
meals for the food-effect BA studies should be the high-fat, high-
calorie test meal described above.
Hope this helps you.
Regards,
Jyothi Kakani,
Manager - QA
Jubilant Clinsys Limited
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