Only fed study [Design Issues]
'…, we recommend that where the focus is on release of the drug substance from the drug product into the systemic circulation, a single-dose, fasting study be performed.'
'In addition to a BE study under fasting conditions, we recommend a BE study under fed conditions for all orally administered immediate-release drug products, with the following exceptions:
Anyhow, if the food effect documented in the reference's SmPC is safety-related (i.e., AEs due to GI-disturbances), you may start an argument.
Remark: in such a case European Guidelines call only for a fed study.
Edit: Links corrected for FDA’s new site. [Helmut]
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Helmut Schütz
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Science Quotes
Complete thread:
- Only fed study roody 2005-10-04 19:10 [Design Issues]
- Only fed studyHelmut 2005-10-04 19:45
- Only fed study Jaime_R 2005-10-04 20:42
- Only fed studyHelmut 2005-10-04 19:45