Meal menu for FAST/FED BABE study [Design Issues]
Hi!
If there is a food effect...
Requirement is a strong word. Generally, also Guidelines expect you to standardise diet. They call it recommendation, but I am sure there is a risk, that an assessor may have some questions on this issue.
Besides: we are talking about a (high-fat) fed study. Thus, subsequent meals could easily interact with your formulation (if only by delaying gastric emptying) and also with the API.
Sure, direct interaction may be rare, but why take the risk?
It's only my opinion, but without a good reason I would not accept that there is a difference in meals between periods.
(Or between studies, if I could decide, but as comparisons between studies are kind of futile...)
You are welcome!
Edit: Full quote removed. Please delete everything from the text of the original poster which is not necessary in understanding your answer; see also this post #5! [Helmut]
❝ We all know that Bioavailability is effected if drug product is taken with food.
If there is a food effect...
❝ in a BABE study apart from fed breakfast (high fat high calorie) there are other meals given after dosing.
❝ 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?
Requirement is a strong word. Generally, also Guidelines expect you to standardise diet. They call it recommendation, but I am sure there is a risk, that an assessor may have some questions on this issue.
Besides: we are talking about a (high-fat) fed study. Thus, subsequent meals could easily interact with your formulation (if only by delaying gastric emptying) and also with the API.
Sure, direct interaction may be rare, but why take the risk?
It's only my opinion, but without a good reason I would not accept that there is a difference in meals between periods.
(Or between studies, if I could decide, but as comparisons between studies are kind of futile...)
❝ thanks
❝ pundalik pai
You are welcome!
Edit: Full quote removed. Please delete everything from the text of the original poster which is not necessary in understanding your answer; see also this post #5! [Helmut]
Complete thread:
- Meal menu for FAST/FED BABE study pundlikpai 2016-09-27 07:36 [Design Issues]
- Meal menu for FAST/FED BABE studyRelaxation 2016-10-07 18:22
- Meal menu for FAST/FED BABE study HV 2016-10-10 14:16