Solubility based Biowaiver [Dissolution / BCS / IVIVC]

posted by Amalia – Greece, 2018-10-02 10:59 (2004 d 17:30 ago) – Posting: # 19360
Views: 5,826

Dear Obinoscopy,

what I guess I should have clarified is that the reason we are trying to use this justification is because the lower strength is not proportional in terms of excipients.

❝ The advise was given by an "external clinical expert".


I presume this is why we were advised to follow the solubility path for a biowaiver? That is why we are wondering whether we should perform the solubility tests at the API or the final formulation.
What do you think?

Kind Regards,

Amalia

Complete thread:

UA Flag
Activity
 Admin contact
22,957 posts in 4,819 threads, 1,636 registered users;
90 visitors (0 registered, 90 guests [including 7 identified bots]).
Forum time: 03:29 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