Immediate release fixed dose combination product [Regulatives / Guidelines]

posted by Dr_Dan  – 2020-03-11 11:47 (362 d 05:09 ago) – Posting: # 21240
Views: 3,364

Hello ping4santosh,
Even if you aim at substitution indication (improvement of patient's compliance) presenting co-prescription data and therapeutic guidelines recommending the co-administration will not suffice as long as you are unable to present clinical data demonstrating safety and efficacy of the respective combination. IMHO it will be hard to identify a new FDC which can be approved without a phase III study (at least in western Europe).

Kind regards and have a nice day

Complete thread:

 Admin contact
21,371 posts in 4,463 threads, 1,495 registered users;
online 12 (0 registered, 12 guests [including 3 identified bots]).
Forum time: Monday 16:57 CET (Europe/Vienna)

When puzzled, it never hurts to read the primary documents 
a rather simple and self-evident principle that has, nonetheless,
completely disappeared from large sectors
of the American experience.    Stephen Jay Gould

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