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

posted by Maitri – India, 2018-09-21 21:49 (2839 d 20:19 ago) – Posting: # 19297
Views: 4,090

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
23,656 posts in 4,994 threads, 1,570 registered users;
252 visitors (0 registered, 252 guests [including 21 identified bots]).
Forum time: 18:08 CEST (Europe/Vienna)

Try to learn something about everything
and everything about something.    Thomas Henry Huxley

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