Regulatory Submission in Europe in Absence of Reference product [Regulatives / Guidelines]

posted by dshah – India, 2021-03-23 09:51 (24 d 21:15 ago) – Posting: # 22290
Views: 304

Hi Abhay Patil!
In absence of Innovator product in EU and UK market for FDC, you may have to do BE against individual drug substance innovator product. Please see Guideline on clinical development of fixed combination medicinal products.
Regards,
Dshah

Complete thread:

Activity
 Admin contact
21,419 posts in 4,475 threads, 1,509 registered users;
online 9 (0 registered, 9 guests [including 1 identified bots]).
Forum time: Saturday 08:06 CEST (Europe/Vienna)

I never did anything worth doing by accident,
nor did any of my inventions come by accident;
they came by work.    Thomas Alva Edison

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