Meal menu for FAST/FED BABE study [Design Issues]

posted by pundlikpai – India, 2016-09-27 09:36 (2760 d 17:41 ago) – Posting: # 16686
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Hello everyone.
We all know that Bioavailability is effected if drug product is taken with food.
in a BABE study apart from fed breakfast (high fat high calorie) there are other meals given after dosing.
I have a query. will be helpful if it gets solved in this forum.

Is there any requirement that these meals i.e lunch snacks and dinner (except high fat high calorie breakfast) need to be identical/same for fast & fed studies of same product/filing?

thanks
pundalik pai


Edit: Category changed; see also this post #1. [Helmut]

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