With food administration [Design Issues]

posted by dshah  – India/United Kingdom, 2022-01-20 12:49 (319 d 03:37 ago) – Posting: # 22735
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Dear SerhiiP!
As per the EMA guideline-"In case the study is to be performed during fed conditions, the timing of administration of the drug product in relation to food intake is recommended to be according to the SmPC of the originator product. If no specific recommendation is given in the originator SmPC, it is recommended that subjects should start the meal 30 minutes prior to administration of the drug product and eat this meal within 30 minutes."
Please find the guideline here.

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