Bioequivalence and Bioavailability Forum

Dear Detlew,

Thank you for the reply.

❝ ❝ We wanted to find the Fieller's Confidence Interval for the ratio of means as mentioned in the below guideline

❝ ❝ ...

❝

❝ Can't see any hint in the direction of Fieller's confidence interval in your posted text.

As per the Guideline, To establish bioequivalence for the primary endpoint, the 90% confidence interval of the test/reference ratio of the mean percent change from baseline to week 12 in the inflammatory (papules and pustules) lesion counts and in the non-inflammatory (comedones) lesion counts should be contained within [0.80, 1.25], using the per protocol (PP) population.

As this is untransformed data, we have to use Fieller's Confidence Interval for the ratio of means.

This is the reason, I was asked this question.

Kindly provide any other thoughts on this.