Immediate release fixed dose combination product [Regulatives / Guidelines]

posted by ElMaestro  – Denmark, 2020-03-09 13:50 (586 d 08:50 ago) – Posting: # 21228
Views: 3,647

Hello ping4santosh,

in addition to what ohlbe has said, I'd like to mention that the guideline does open up for "substitution"; read section 4.2.
Substitution on its own may not be adequate justification for the existence of your FDC (that's the issue with the section Ohlbe quoted), and that's why many companies in your situation will need to prove that the monos are co-prescribed in your target markets (unless they wish to spend trillions on clin. trials to prove some superiority over standard care).
Co-prescribing info, in turn, is "easily" obtained from third party sources but you will also be paying an arm and a leg for that info. You will not find the reports by googling. It may nevertheless be exactly what you need to justify the FDC.

Check also if "initial therapy" applies with your product - section 4.3. I can't determine that from the info you wrote.

Pass or fail!
ElMaestro

Complete thread:

Activity
 Admin contact
21,729 posts in 4,543 threads, 1,543 registered users;
online 10 (0 registered, 10 guests [including 4 identified bots]).
Forum time: Saturday 23:41 CEST (Europe/Vienna)

If you want to converse with me,
define your terms.    Voltaire

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