Solubility based Biowaiver [Dissolution / BCS / IVIVC]

posted by wienui  – Germany/Oman, 2018-10-02 06:52 (2005 d 00:50 ago) – Posting: # 19358
Views: 5,910

Dear Amalia & Scopy,

I agree with Scopy only an important point to mention that the dissolution tests of the lower strength must be conducted against the same Biobatch (the batch which approved via BE study) of the higher strength, otherwise it will not be accepted from the regulatory.

Best regards,

Osama

Cheers,
Osama

Complete thread:

UA Flag
Activity
 Admin contact
22,957 posts in 4,819 threads, 1,636 registered users;
92 visitors (0 registered, 92 guests [including 10 identified bots]).
Forum time: 06:43 CET (Europe/Vienna)

With four parameters I can fit an elephant,
and with five I can make him wiggle his trunk.    John von Neumann

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