Bioequivalence and Bioavailability Forum

Main page Policy/Terms of Use Abbreviations Latest Posts

 Log in |  Register |  Search

Back to the forum  2018-07-22 07:12 CEST (UTC+2h)

If the reference product does not pass in BCS ?? [Dissolution / BCS / IVIVC]

posted by Mauricio Sampaio - Brazil, 2018-01-10 13:59  - Posting: # 18160
Views: 873

Dear Steven

» My guess would be that the reference product does not achieve the pre-set limit of 85% at 15 or 30 minutes, if you say "does not pass"? Could that be right?

YES!!!!:-D

» But you will always have to discuss it and provide a convincing statement, so its hard to provide the one solution here.

Thank you for your comments Steven! I think so that a bioequivalence test in vivo is so close to be requested as a second step!:crying:

Complete thread:

Back to the forum Activity
 Mix view
Bioequivalence and Bioavailability Forum |  Admin contact
18,547 posts in 3,941 threads, 1,192 registered users;
online 18 (1 registered, 17 guests [including 16 identified bots]).

Ignorance more frequently begets confidence
than does knowledge.    Charles Darwin

The BIOEQUIVALENCE / BIOAVAILABILITY FORUM is hosted by
BEBAC Ing. Helmut Schütz
HTML5 RSS Feed