Flecainide- NTID [Design Issues]

posted by The Outlaw Torn – Europe, 2018-06-28 08:57 (819 d 13:22 ago) – Posting: # 18987
Views: 2,431

» 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. :-D

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.

Complete thread:

 Admin contact
21,074 posts in 4,394 threads, 1,468 registered users;
online 2 (0 registered, 2 guests [including 2 identified bots]).
Forum time: Thursday 22:20 CEST (Europe/Vienna)

Enlightenment is man’s emergence from his self-imposed nonage
for which he himself was responsible.
Nonage is the inability to use one’s own intellect
without the direction of another.    Immanuel Kant

The Bioequivalence and Bioavailability Forum is hosted by
BEBAC Ing. Helmut Schütz