pundlikpai
☆    

India,
2016-09-27 09:36
(2739 d 13:03 ago)

Posting: # 16686
Views: 3,681
 

 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]
Relaxation
★    

Germany,
2016-10-07 20:22
(2729 d 02:16 ago)

@ pundlikpai
Posting: # 16707
Views: 2,856
 

 Meal menu for FAST/FED BABE study

Hi!

❝ 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]
HV
☆    

India,
2016-10-10 16:16
(2726 d 06:23 ago)

@ pundlikpai
Posting: # 16709
Views: 2,776
 

 Meal menu for FAST/FED BABE study

Hello Pundalikpai,

Bioequivalence as a thumb rule :thumb up: works on a principle that all other factors are standard / identical - apart from the formulations being evaluated, i.e. test and reference. This applies to food intake, posture restrictions, water restrictions etc.

IMO standardization in food menu between two periods is important for unbiased evaluation of formulation performance against the reference.

Yes, but it is of little importance to keep identical menu between two separate studies, the standardization should be maintained within the study...:yes:

Cheers!
HV
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