Solubility based Biowaiver [Dissolution / BCS / IVIVC]

posted by Amalia – Greece, 2018-10-02 08:59 (1457 d 00:27 ago) – Posting: # 19360
Views: 5,318

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
22,391 posts in 4,685 threads, 1,595 registered users;
online 4 (0 registered, 4 guests [including 2 identified bots]).
Forum time: Wednesday 09:27 CEST (Europe/Vienna)

The real struggle is not between the right and the left
but between the party of the thoughtful
and the party of the jerks.    Jimmy Wales

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