Flecainide- NTID [Design Issues]

posted by dr.who – Macedonia, 2018-06-28 00:27 (2121 d 12:18 ago) – Posting: # 18983
Views: 3,872

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.

Complete thread:

UA Flag
Activity
 Admin contact
22,986 posts in 4,823 threads, 1,663 registered users;
66 visitors (0 registered, 66 guests [including 8 identified bots]).
Forum time: 12:45 CEST (Europe/Vienna)

Art is “I”; science is “we”.    Claude Bernard

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