Flecainide- NTID [Design Issues]
My question is related to Flecainide. In the available literature data it is stated that flecainide is a NTID. As per the EU Guideline for BE in the case of NTID the limits are tightened, but no available PAR present a BE for flecainide with tightened limits. Also except Canada no other region have a specific list for NTIDs and for EU it is stated that is evaluated on case by case. What is your experience in design a BE of Flecainide, should the recommendation for NTID design be followed or a standard BE study design is acceptable.