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

posted by Mauricio Sampaio  – Brazil, 2019-07-22 19:43  – Posting: # 20429
Views: 1,572

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

Complete thread:

Activity
 Admin contact
20,793 posts in 4,353 threads, 1,445 registered users;
online 12 (0 registered, 12 guests [including 7 identified bots]).
Forum time: 10:28 UTC (Europe/Vienna)

In God we trust;
all others must bring data.    W. Edwards Deming

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