Immediate release fixed dose combination product [Regulatives / Guidelines]

posted by Dr_Dan  – 2020-03-11 11:47 (201 d 04:34 ago) – Posting: # 21240
Views: 3,152

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
Dr_Dan

Complete thread:

Activity
 Admin contact
21,083 posts in 4,398 threads, 1,468 registered users;
online 3 (1 registered, 2 guests [including 2 identified bots]).
Forum time: Monday 17:22 CEST (Europe/Vienna)

A central lesson of science is that to understand complex issues
(or even simple ones), we must try to free our minds of dogma and
to guarantee the freedom to publish, to contradict, and to experiment.
Arguments from authority are unacceptable.    Carl Sagan

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