Bioequivalence and Bioavailability Forum

Dear Andrew!

❝ I know little about pharmaceutics, but I think that the new formulation

❝ involves some sort of cyclodextran, which I guess means that the line "if

❝ any excipients interact with the drug substance (e.g. complex formation),

❝ or otherwise affect the disposition of the drug substance" in Appendix II

❝ would apply.

Probably to likely: yes.

❝ I expect we'll see increased use of the sequential design in the years to

❝ come.

Me too. I made it my standard for 2×2 studies, unless I have a lot of data from previous studies beforehand.

❝ I'll have my statistician get intimate / cosy with Potvin.

Do so. It's not complicated at all. Don't forget to modify the statistical model if you proceeded to stage 2 (see here).