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

posted by HV – India, 2016-10-10 16:16 (3545 d 23:22 ago) – Posting: # 16709
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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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