FDA and outliers [Study As­sess­ment]

posted by mittyri – Russia, 2018-12-11 16:38  – Posting: # 19681
Views: 1,910

Dear Mann,

I don't think the position of FDA is different.
Please see this old post.

Do you have any experience of BEQ analysis for submission in FDA/EMA jurisdiction?
Where is the idea of outliers coming from?
Do the results without any outliers analysis also show not-BE?

Kind regards,
Mittyri

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