BCS Biowaiver for oral suspension [Dissolution / BCS / IVIVC]

posted by wienui  – Germany, Oman, 2018-11-23 19:36 (671 d 02:46 ago) – Posting: # 19648
Views: 2,486

Dear averroes1304,

» Is it possible to apply the biowaiver based on the BCS system for oral suspensions with systemic effect?

Yes, if you apply for EU region ,WHO & some other countries
No for USA & some other countries

Please refer to this article, https://www.ncbi.nlm.nih.gov/pubmed/29382433

Best regards,
Osama

Cheers,
Osama

Complete thread:

Activity
 Admin contact
21,074 posts in 4,394 threads, 1,468 registered users;
online 3 (0 registered, 3 guests [including 2 identified bots]).
Forum time: Thursday 23:22 CEST (Europe/Vienna)

Enlightenment is man’s emergence from his self-imposed nonage
for which he himself was responsible.
Nonage is the inability to use one’s own intellect
without the direction of another.    Immanuel Kant

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