EU: Fed state according to the reference’s SmPC [Design Issues]

posted by Helmut Homepage – Vienna, Austria, 2021-09-24 16:07 (368 d 00:02 ago) – Posting: # 22596
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Hi BR,

» What is the most appropriate condition for performing the BE study in this situation, fed or fasting :-) ?

IMHO, in fed state. Justification:Nevertheless, some (or most?) agencies may ask you for studies vs the mono-components (if marketed). See this post.

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