Flecainide- NTID [Design Issues]

posted by dr.who – Macedonia, 2018-06-27 23:32 (1218 d 06:54 ago) – Posting: # 18985
Views: 2,736

Thanks for the feedback.

Yes,you are right. All availabe PARS show BE with standard acceptance limits.

But, the originator SmPC states that flecainide is NTID:
"Flecainide as a narrow therapeutic index drug requires caution and close monitoring when switching a patient to a different formulation."

https://www.medicines.org.uk/emc/product/829/smpc

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/

Complete thread:

Activity
 Admin contact
21,760 posts in 4,550 threads, 1,545 registered users;
online 6 (0 registered, 6 guests [including 4 identified bots]).
Forum time: Thursday 06:26 CEST (Europe/Vienna)

Always remember that you are absolutely unique.
Just like everyone else.    Margaret Mead

The Bioequivalence and Bioavailability Forum is hosted by
BEBAC Ing. Helmut Schütz
HTML5