Meal menu for FAST/FED BABE study [Design Issues]
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]
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]
Complete thread:
- Meal menu for FAST/FED BABE studypundlikpai 2016-09-27 07:36 [Design Issues]
- Meal menu for FAST/FED BABE study Relaxation 2016-10-07 18:22
- Meal menu for FAST/FED BABE study HV 2016-10-10 14:16