Reference Scale Average Bioequivalence Approach: ANVISA, Brazil [Regulatives / Guidelines]

posted by Maitri – India, 2018-09-21 21:49 (2015 d 02:02 ago) – Posting: # 19297
Views: 2,355

Hello,

Can any one comment on acceptability of Reference Scale Bioequivalence Approach for ANVISA ( Regulatory agency of Brazil) for highly variable drugs? Do they accept RSABE study design for Highly variable drug compounds?

Thanks & Regards,
Maitri Sanghavi

Complete thread:

UA Flag
Activity
 Admin contact
22,957 posts in 4,819 threads, 1,636 registered users;
89 visitors (0 registered, 89 guests [including 3 identified bots]).
Forum time: 22:51 CET (Europe/Vienna)

Nothing shows a lack of mathematical education more
than an overly precise calculation.    Carl Friedrich Gauß

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