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

posted by Maitri – India, 2018-09-21 21:49 (2036 d 04:18 ago) – Posting: # 19297
Views: 2,407

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
22,986 posts in 4,823 threads, 1,671 registered users;
74 visitors (0 registered, 74 guests [including 5 identified bots]).
Forum time: 02:07 CEST (Europe/Vienna)

The only way to comprehend what mathematicians mean by Infinity
is to contemplate the extent of human stupidity.    Voltaire

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