Bioequivalence and Bioavailability Forum

Dear Jo!

❝ First of all, I would like to thank you for the promptitude in giving me

❝ very useful answers in other occasions.

Welcome.

❝ In the Public Assessment Report [...] what is the meaning of CV presented in

❝ the tables of PK parameters?

This is just the total (inter- + intra-subject variability) of the treatments.

❝ Can I use these data for development of a new bioequivalence study?

No. Although the confidence intervals are given, you would need the sample size of the study to calculate CV_intra (little algebra, or David Dubins' FARTSSIE). So, bad look for Studies 1-2. With another little algebra it's possible to show that Study 3 most likely was performed in 53 subjects, and Study 4 in 56.
Omeprazole is a nasty drug. Quite often outliers are seen (mainly the coating of the reference fails), which leads to a high CV_intra and therefore a large CI... If have seen (lucky) studies passing in 32 subjects, and others failing in 120...
Since nonparametrical methods and Reference Scaled Average Bioequivalence are

Taboo
in the EU

you only may cross your fingers and pray (a sequential design does not help either, because an outlier may hit you in the second step as well).