Solubility based Biowaiver [Dissolution / BCS / IVIVC]

posted by The Outlaw Torn – Europe, 2018-10-02 09:51 (838 d 10:05 ago) – Posting: # 19361
Views: 4,252

» 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
21,303 posts in 4,441 threads, 1,487 registered users;
online 10 (1 registered, 9 guests [including 2 identified bots]).
Forum time: Sunday 18:57 CET (Europe/Vienna)

No problem can stand the assault of sustained thinking.    Voltaire

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