Solubility based Biowaiver [Dissolution / BCS / IVIVC]

posted by Amalia – Greece, 2018-10-02 12:35 (2121 d 05:04 ago) – Posting: # 19362
Views: 6,279

❝ Where is the difference coming from?


None of the excipients are proportional.

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


The API of the lowest strength is less than 5%. But not of the highest strength for which a BE study was performed.

❝ 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.


I Know. The most probable scenario is that we will perform a BE study. We are just trying to see if a justification can be made.


Edit: Full quote removed. Please delete everything from the text of the original poster which is not necessary in understanding your answer; see also this post #5! Please follow the Forum’s Policy[Helmut]

Complete thread:

UA Flag
Activity
 Admin contact
23,119 posts in 4,859 threads, 1,647 registered users;
36 visitors (1 registered, 35 guests [including 9 identified bots]).
Forum time: 17:39 CEST (Europe/Vienna)

You can’t really say “similar” if it’s the same again you want.
“Similar” means something different.    Anthony Burgess

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