Fed conditions → timing of meal [Design Issues]

posted by zuzanna – Poland, 2024-07-31 09:54 (262 d 09:53 ago) – Posting: # 24108
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Dear Forum members,

Please share your thoughts regarding the timing of meal in the situation below:

SmPC of Reference: administer the drug at the beginning of meal
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.
ICH M13A draft guideline: For a fed BE study, it is recommended that subjects start the meal 30 minutes before administration of the drug product and consume the meal within 30 minutes (and no reference to the label/SmPC)
First sampling point: 20 min (sic!), then 40 min etc…

What would you do in this situation: 1) start the meal within 5 min following drug administration (and keep or move the first sampling point?) or 2) start the meal 30 min before drug administration (let’s say “standard fed conditions” but not fully in line with SmPC)?

I’m confusing, grateful for all suggestions!

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