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

posted by Mauricio Sampaio  – Brazil, 2019-07-19 22:29  – Posting: # 20407
Views: 703

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

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