No way [Dissolution / BCS / IVIVC]

posted by Ohlbe – France, 2019-01-27 18:18 (838 d 21:07 ago) – Posting: # 19813
Views: 1,763

Dear yuvaneshwari,

» Since API is in solution state filled in capsule, its solubility/bioavailability is improved tremendously.

» In the above scenario, can we consider for BCS based waiver approach ?

I think you have answered your own question. If solubility is the limiting factor, and your product has an improved solubility compared to the reference, how could you justify any kind of biowaiver ?

In any case: BCS-based biowaivers are only possible for class I and III products. Not the slightest chance if you're dealing with class II or IV.

Regards
Ohlbe

Complete thread:

Activity
 Admin contact
21,462 posts in 4,487 threads, 1,514 registered users;
online 2 (0 registered, 2 guests [including 2 identified bots]).
Forum time: Saturday 16:25 CEST (Europe/Vienna)

By all means let’s be open-minded, but not so open-minded
that our brains drop out.    Richard Dawkins

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