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Back to the forum  2018-07-16 07:22 CEST (UTC+2h)

Flecainide- NTID [Design Issues]

posted by dr.who - Macedonia, 2018-06-27 22:27  - Posting: # 18983
Views: 298

Nice to meet you all since it is my first time writing on the forum.

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.

Thanks.

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