Bioequivalence and Bioavailability Forum

Hi all,

some mentally deranged weirdo published a paper in the DIA journal Therapeutic Innovation & Regulatory Science. Apparently the paper makes inference about the type I error when outlier removal takes place as described in the Canadian guidance. The author writes:

"A user named “zizou” asked a question on an internet forum in 2019 [6]; paraphrased, the question was: Wouldn’t such an outlier exclusion practice result in decreased variability without affecting the expected geometric mean ratio of Test and Reference and thus lead to increased type I error (patient’s risk, risk of declaring bioequivalence for a bioinequivalent product)?"

If I am not mistaken the author is referring to this post from zizou.

The conclusion is pretty clear - zizou was entirely correct in expressing that concern. And the author is grateful . The ball is in HC's court now and the final word on this matter has not been said.