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RegisterFlecainide- NTID [Design Issues]
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/
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:
- Flecainide- NTID dr.who 2018-06-27 22:27
![[Mix]](https://static.bebac.at/img/mix.png "open in Mix view")
- Flecainide- NTID ElMaestro 2018-06-27 22:39
- Flecainide- NTIDdr.who 2018-06-27 23:32
- Flecainide- NTID The Outlaw Torn 2018-06-28 08:57
- Flecainide- NTIDdr.who 2018-06-27 23:32
- Flecainide- NTID ElMaestro 2018-06-27 22:39
Ing. Helmut Schütz