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

posted by wienui  – Germany/Oman, 2018-11-23 20:36 (1979 d 08:13 ago) – Posting: # 19648
Views: 4,544

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:

UA Flag
Activity
 Admin contact
22,993 posts in 4,828 threads, 1,656 registered users;
100 visitors (0 registered, 100 guests [including 4 identified bots]).
Forum time: 05:49 CEST (Europe/Vienna)

Never never never never use Excel.
Not even for calculation of arithmetic means.    Martin Wolfsegger

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