Bioequivalence and Bioavailability Forum

Dear All,

We have small statistical problem in one BE partial replicate study data, and this study having 48 subjects data with this data BE acceptance criteria is not meeting due to two subject showing low concentrations

Subject I-Test has shown low concentration (1/10 times) when compared with Reference formulations (R1&R2).

Subject II-one Reference has shown low concentration (1/10 times) when compared with test & other Reference formulation.

If we are excluding these two subjects, variability observed is<30% and met the 90% CI.

If we are including these two subject, variability observed is >30% and not met the 95% bound.

So, how can we justify those two subjects data as outliers/anomalous and how to perform statistical analysis in such a case?

Please clarify

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Edit: Category changed. [Helmut]