Outliers US FDA submission [Outliers]

posted by ElMaestro  – Denmark, 2013-03-04 12:47 (3746 d 07:56 ago) – Posting: # 10148
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Dear Chiku,

These cases are unfortunately seen now and then. But that's not the end of the world.

❝ After reviewing, the results we observed that one particular subject is qualifying as an statistical outlier for all the three PK parameters i.e Cmax, AUC0-t and AUC0-inf (Reference product was not released at all). The data is within BE acceptance limits after deleting the subject 83, here is the data for your reference.

Could you just briefly explain what you mean when you say it is a statistical outlier? Did you do a formal statistical test?
You mention ref. not released - sure? Or ref. possibly not ingested or not absorbed or not analysed correctly to BLQ? Did you audit the study, clin. + bioanalytics?

Pass or fail!

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