Outlier in a BE study [Outliers]

posted by luvblooms  – India, 2014-01-27 10:11 (3415 d 14:11 ago) – Posting: # 12273
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Dear Auditor

❝ Now how to present this data to regulatory (including and excluding outlier or just excluding)?

❝ whether regulatory accepts the such these type of data with outliers? Please explain the about these as early as possible.

I came across a paper “For-Cause” Inspections in Bioequivalence Studies Submitted to the Food and Drug Administration" written by FDA hot-shots ;-) and published in January 2013 in AAPS

In this article, they have not directly mentioned that they do accept re dosing study or not; but have mentioned the redosing study as in example or reason of For-Cause Inspections in Bioequivalence Studies.

Please look in the section Improper study design and conduct examples were it is mentioned as Insufficient number of control subjects in re-dosing study, and lack of SOP in effect at the time of the study related to the conditions that warrant the performance of an outlier test.

So IMHO, if you have a proper justification and procedures in place to justify the outlier test, you may approach to FDA with re-dosing study or contact them through CC for their opinion.

I may be wrong, but this is worth trying...


~A happy Soul~

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