Solubility based Biowaiver [Dissolution / BCS / IVIVC]

posted by The Outlaw Torn – Europe, 2018-10-02 09:51 (1026 d 08:48 ago) – Posting: # 19361
Views: 4,681

» 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".

Where is the difference coming from?

Is the API less than 5% of the total weight of the tablet?

Take a look at the General biowaiver criteria on page 12 of the guideline. If you don't meet the conditions stated in c), you'll need to conduct a BE study at the lower strength too.

Complete thread:

Activity
 Admin contact
21,589 posts in 4,512 threads, 1,530 registered users;
online 18 (0 registered, 18 guests [including 5 identified bots]).
Forum time: Saturday 18:40 CEST (Europe/Vienna)

There are no dangerous thoughts;
thinking itself is dangerous.    Hannah Arendt

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