Outlier in a BE study [Outliers]

posted by riteshsrmc  – India, 2014-01-16 13:44 (3426 d 11:12 ago) – Posting: # 12177
Views: 8,920

Hi Auditor,

By the way to which agency you are filing the product? Agreed with Dan! EMEA has clearly defined the situation in guidance. I would suggest you to look at FDA perspective as well, if you are filing to FDA. FDA does not encourage redosing to handle outliers subjects incase of non-replicate design study wherein you may carry out redosing incase of replicate design. You should be clear they way agency look at the data with or without outliers.

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