Subject outlier for pass study (FDA) [Outliers]

posted by kaushal09 – India, 2012-03-17 08:19 (4421 d 13:58 ago) – Posting: # 8291
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Dear All,

One BA/BE study was meeting acceptance criteria as per FDA retirement. (80-125%). IS this required to check outlier for pass bio-study?
Also if we apply outlier test for bio-study than one subject found as outlier and after excluding that subject, study goes to fail to meet acceptance criteria (80-125).

Please suggest :confused:

Thanks,
Kaushal

Edit: Subject line changed. [Helmut]

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