Reference drugs for triple combination test drug in Russia [Design Issues]

posted by Yura – Belarus, 2019-11-19 22:51 (1175 d 17:08 ago) – Posting: # 20830
Views: 4,355

Hi Beholder,
There is no reason for the regulator not to want to check section 4.5 of the Guideline on clinical development of fixed combination medicinal products :|>
Kind regards,
Yura


Edit: Guideline linked. Also changed the name in signature to the usual one[Mittyri]

Complete thread:

UA Flag
Activity
 Admin contact
22,485 posts in 4,710 threads, 1,603 registered users;
19 visitors (0 registered, 19 guests [including 6 identified bots]).
Forum time: 16:00 CET (Europe/Vienna)

The difference between a surrogate and a true endpoint
is like the difference between a cheque and cash.
You can get the cheque earlier but then,
of course, it might bounce.    Stephen Senn

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