Bioequivalence and Bioavailability Forum

Dear Dipesh!

❝ I would like to know that which method is to be used to find out the

❝ outlier from the QC set used in study sample analysis??

There is no need for a formal 'outlier test'. 33% of the QC samples may be outside ±15% (±20% for the lowest QC) of their respective nominal values.

Example:
QCs at three levels (one > LLOQ, one in midrange, one in high range), all in duplicate.
<3 values at different levels outside ±15% of nominal --> valid batch
>3 values outside ±15% of nominal --> invalid batch
2 values ±15% of nominal at the same level --> invalid batch

❝ Is it acceptable to label any value as statistical outlying value and to be

❝ presented with and without that value in BioAnalytical Report?

Yes, you have to report all measured QC samples; it's good practice to flag values outside the acceptance range.

Details in http://www.fda.gov/cder/guidance/4252fnl.pdf FDA's Guideline (page 15pp).

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Edit: Link corrected for FDA’s new site. [Helmut]