Bioequivalence and Bioavailability Forum

❝ In order to possibly give you some advice more information would be needed. I guess the study was conducted in humans, right?

Yes.

❝ And the AUC was truncated due to the long terminal half life of the drug?

AUC 0-i was measured as well. And the values were about the same as for AUC 0-t. (76.76-102.52)

❝ Comparative dissolution showed f2 values >50 at all three pH levels (1.2, 4.5 and 6.8)?

Because of difficulties with degradation of ivermectin at acidic pH the drug release rate was not measured at pH 1.2. But also at pH 7.0.

❝ The high ANOVA CV was not caused by outlying subjects?

I couldn't find any data about outlier detection. Maybe this was not carried out?

❝ Before you start reformulating your product you need to be sure that the study outcome is valid.

I have to assess the study from a regulatory point of view and give a strategic advice. But it seems to me that the study should be reviewed by a competent statistician first...

Thank you very much for all your comments!