Immediate release fixed dose combination product [Regulatives / Guidelines]

posted by Dr_Dan  – 2020-03-11 10:47 (403 d 09:55 ago) – Posting: # 21240
Views: 3,427

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
21,419 posts in 4,475 threads, 1,508 registered users;
online 13 (0 registered, 13 guests [including 3 identified bots]).
Forum time: Sunday 20:43 UTC (Europe/Vienna)

Nothing fails like success because you do not learn anything from it.
The only thing we ever learn from is failure.
Success only confirms our superstitions.    Kenneth E. Boulding

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