Bioequivalence and Bioavailability Forum

Main page Policy Latest Posts Abbreviations

permeability testing and biowaiver [Dissolution / BCS / IVIVC]

posted by jag009 – NJ, 2012-04-30 22:08 (5175 d 01:19 ago) – Posting: # 8482
Views: 5,277

Also make sure the Innovator IR product meets the in-vitro release spec that is suggested by the FDA guidance. Something like NLT 85% dissolved in 15 mins, otherwise you can't file a BCS class 1 biowaiver.

Complete thread:

permeability testing and biowaiver Compliance 2012-04-28 13:13
- permeability testing and biowaiver drgunasakaran1 2012-04-30 07:09
- permeability testing and biowaiver Dr_Dan 2012-04-30 14:13
- permeability testing and biowaiverjag009 2012-04-30 20:08

Admin contact
23,656 posts in 4,994 threads, 1,570 registered users;
384 visitors (0 registered, 384 guests [including 110 identified bots]).
Forum time: 23:27 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