VP
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2009-04-04 14:47
(6291 d 05:54 ago)

Posting: # 3463
Views: 3,415
 

 Meal Menu [Design Issues]

Dear all

I would like to know is it requried to get approval for meal menu (food provided to volunteers during BA/BE study) by IEC.

Regards
VP

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Edit: Category changed. [Helmut]
Helmut
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2009-04-04 15:55
(6291 d 04:47 ago)

@ VP
Posting: # 3464
Views: 2,768
 

 Specifications presented to IEC

Dear VP!

No big deal. You should mention in the protocol that meals will be standardized. Meals should be identical in all treatment periods. You should provide the time points after administration and the type of meals (e.g., breakfast, lunch, dinner, snack, etc.).
If you are dealing with a food study the composition and caloric breakdown of the breakfast should be given.

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VP
☆    

2009-04-11 13:05
(6284 d 07:36 ago)

@ Helmut
Posting: # 3509
Views: 2,672
 

 Specifications presented to IEC

thanks for reply.

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Edit: Full quote removed. Please see this post! Helmut
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