BEQ study between different strengths [Regulatives / Guidelines]

posted by Aga – US, 2017-01-09 16:13 (2657 d 10:33 ago) – Posting: # 16942
Views: 4,607

Hello,
Will be bioequivalence study between different strengths (40 mg-test product vs 80 mg-reference) accepted by EU Agencies in generic application?
I've searched for guidelines but can't find a definite answer.
best regards,
Aga

Complete thread:

UA Flag
Activity
 Admin contact
22,988 posts in 4,825 threads, 1,656 registered users;
83 visitors (0 registered, 83 guests [including 2 identified bots]).
Forum time: 03:46 CEST (Europe/Vienna)

The whole purpose of education is
to turn mirrors into windows.    Sydney J. Harris

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