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

posted by Mauricio Sampaio  – Brazil, 2019-07-22 19:43 (698 d 17:56 ago) – Posting: # 20429
Views: 2,409

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
21,530 posts in 4,499 threads, 1,523 registered users;
online 8 (0 registered, 8 guests [including 3 identified bots]).
Forum time: Sunday 13:40 UTC (Europe/Vienna)

Intellect distinguishes between the possible and the impossible;
reason distinguishes between the sensible and the senseless.
Even the possible can be senseless.    Max Born

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