Bioequivalence and Bioavailability Forum

Dear Vasily!

❝ I can hardly be treated as insider since I am not related to Russian regulatory in any way (however I live inside Russia, so that might qualify me as a Russian insider)

Perfect qualification! I’m not related to any Agency as well, but feel qualified enough to dabble in a lot of stuff here.

❝ Unfortunately it is very difficult and time consuming to get official response in paper clarifying agency's view so you usually can test the system only by submitting your protocol.

Same procedure as everywhere. Even if you go for an advisory meeting recommendations are non-binding – both for the agency and the sponsor.

❝ i must admit that once we managed to receive pre-submission agency's recommendations for our novel cardioplegic solution. Recommendations included suggestion to test the possible effect of our solution on the ability to drive.

That’s a nice one!

❝ ❝ BTW, since the guideline only mentions 2×2 cross-overs how to you deal with drugs with long-half lives or studies in patients with unstable diseases (only parallel design feasible in both cases)?

❝

❝ Parallel design is allowed. I know that parallel BE study in glaucoma patients (sponsored by E. European company) was recently approved.

Good to hear. Makes sense.