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

posted by Mauricio Sampaio  – Brazil, 2019-07-22 21:43 (435 d 03:57 ago) – Posting: # 20429
Views: 1,870

Hi,

» You mean what is the tech reason to perform disso testing (T vs R) at each strength?»

Yes! For example: three strenght of 80 mg, 40 mg and 20 mg and the drug is class 1. I understand that BCS in three pHs (1,2; 4,5 and 6,8) is requeried to strenght 80 mg (Test 80 mg vs Reference 80 mg)

But, I do not understand why is necessary to perform a BSC approach to others strength (Test 40 mg vs Reference 40 mg and Test 20 mg vs Reference 20 mg).

If, there is a biowaiver for strenght of 80 mg, I could make compare Test 80 mg vs Test 40 mg and Test 80 mg vs Test 20 mg, in an only pH condiction (for example: 4,5)?

BR

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