BSC approach at each strength? [Dissolution / BCS / IVIVC]

posted by Mauricio Sampaio  – Brazil, 2019-07-19 22:29 (1124 d 19:37 ago) – Posting: # 20407
Views: 3,567

Dear all, happy to write here again!

According ICH guideline M9 on biopharmaceutics classification system based biowaivers, is said: "For products with more than one strength the BCS approach should be applied for each strength, i.e., it is expected that test and reference product dissolution profiles are compared at each strength."

My question is: If a biowaiver test (vitro) according BCS replaces a bioequivalence test (in vivo), why not performing just one BCS approach for high strengh (test and reference) and after to do a compare by dissolution test of Tested product (high strengh) versus Test product (low strengh) in an only dissolution medium?

What is the technical reason to performing the BSC approach at each strength?

I really appreciate your opinion!

Best regards

Complete thread:

UA Flag
Activity
 Admin contact
22,305 posts in 4,668 threads, 1,587 registered users;
online 14 (1 registered, 13 guests [including 9 identified bots]).
Forum time: Wednesday 18:06 CEST (Europe/Vienna)

There is no point in being precise when you don’t know
what you’re talking about.    attributed to John Tukey

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