Bioequivalence and Bioavailability Forum

❝ Thanks for the feedback.

❝ Also, I found this study which consider the NTI for flecainide and regulatory requirements per region.\

❝ https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4412688/

Interesting paper. Funded by Meda Pharmaceuticals. Hmmmmm.

As a pharmacist, I've always categorized flecainide as an NTI. But I've had no exposure to it while in my pharma life. Had I drawn up the protocol (without seeing any PARs), I'd have been tempted to use narrowed CIs. Having seen the PARs, I'm no longer sure. The problem with Europe is that they don't abide by precedent as a principle like the US does (though we always mention it when we have a precedent; you know, put the pressure on the authorities to find a way to reject it). Anyway, I would likely write up the protocol with standard CIs and reference the PARs you've found, and go from there. If the authorities point out the fact that flecainide is an NTID, point them back to the PARs; volley back and forth until someone blinks (usually you). Then provide them the data with narrowed CIs at day 106. Looks like it displays low variability from the UKPAR, so you're likely fine with either CIs.