Flecainide- NTID [Design Issues]

posted by dr.who – Macedonia, 2018-06-28 01:32 (2152 d 14:30 ago) – Posting: # 18985
Views: 3,336

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:

UA Flag
Activity
 Admin contact
23,029 posts in 4,834 threads, 1,644 registered users;
21 visitors (0 registered, 21 guests [including 6 identified bots]).
Forum time: 16:03 CEST (Europe/Vienna)

We must be careful not to confuse data with the abstractions
we use to analyze them.    William James

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