Outlier in a BE study [Outliers]

posted by Helmut Homepage – Vienna, Austria, 2014-01-16 15:54 (3840 d 23:39 ago) – Posting: # 12181
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Hi Kumar,

❝ FDA does not encourage redosing to handle outliers subjects incase of non-replicate design study…


Correct.

❝ … wherein you may carry out redosing incase of replicate design.


I don’t think so – at least in a fully replicated design (see this post). In a partial replicate – if the “outlier” occurred after T – I would not perform a re-dosing study without contacting FDA OGD’s review stuff beforehand.

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