RSABE - ANVISA [Regulatives / Guidelines]

posted by d_labes  – Berlin, Germany, 2018-09-22 14:11 (1120 d 19:21 ago) – Posting: # 19298
Views: 1,675

Dear Maitri,

» 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 compunds?

Have you ever discovered the search field in the upper right corner of the forum?

Use it and you will find some threads dealing with the ANVISA specifications for scaled ABE. E.g. this one.

What do you think: If they have specifications for scaled ABE, do they accept studies using that approach?

Regards,

Detlew

Complete thread:

Activity
 Admin contact
21,730 posts in 4,544 threads, 1,543 registered users;
online 10 (1 registered, 9 guests [including 6 identified bots]).
Forum time: Sunday 09:33 CEST (Europe/Vienna)

Be very, very careful what you put into that head,
because you will never, ever get it out.    Thomas Wolsey

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