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Can a non-vegetarian diet be replaced with a veg diet with equivalent
calorific value? Will it affect pk in any ways?
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Diet should be identical/same in all the periods of BE study. We can
select either veg or non veg menu depending on the study requirement
and food habit of subjects. Whatever menu we select, should contain
high fat value i.e. 80-1000 Kcal, out of which 50% should come from
fat. The remaining should contain protein and carbohydrate.
regards
Kalpan Shah
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The following message was posted to: PharmPK
Dear Saikumar,
You can go ahead with the vegetarian diet, provided you follow the
percentages of fat, carbs and proteins and the calorific value as
recommended by the regulatory authority of the country where you
intend to file the submission. In my opinion, there should be no
problem with the PK. However, it is ideal to have a method/system by
which you can identify volunteers in your databank having non-veg
diet. In case you have a good number of volunteers having non-veg
diet, you can provide them with non-veg food, thus trying to come
closer to the recommendations.
Regards,
Dr. Gagandeep Singh
Head - Clinical Research
BioArc Research (Alembic Ltd)
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