Flecainide- NTID [Design Issues]

posted by dr.who – Macedonia, 2018-06-27 23:32 (849 d 16:51 ago) – Posting: # 18985
Views: 2,475

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/

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