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

posted by Mauricio Sampaio  – Brazil, 2019-07-19 22:29  – Posting: # 20407
Views: 375

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:

Activity
 Mix view
Bioequivalence and Bioavailability Forum |  Admin contact
19,685 posts in 4,176 threads, 1,351 registered users;
online 13 (0 registered, 13 guests [including 7 identified bots]).
Forum time (Europe/Vienna): 00:44 CEST

Normality is a myth; there never was, and never will be,
a normal distribution.    Roy C. Geary

The BIOEQUIVALENCE / BIOAVAILABILITY FORUM is hosted by
BEBAC Ing. Helmut Schütz
HTML5