Additional Strength Biowaiver Requirements [Dissolution / BCS / IVIVC]

posted by Obinoscopy  – USA, 2020-07-18 01:13 (223 d 23:19 ago) – Posting: # 21738
Views: 875

Hi dshah

» I believe 2.5X8 tab Vs 20 mg, 10X2 tab vs 20 mg and 15 vs 20 mg strength using 0.4% SDS media is one of the option, but is there any other options for dissolution comparision?

I am not well versed in Additional Strength Biowaivers but I think one of the basic requirements is that the dissolution media should not contain any surfactant at all.

Scopy

Complete thread:

Activity
 Admin contact
21,357 posts in 4,459 threads, 1,492 registered users;
online 5 (0 registered, 5 guests [including 4 identified bots]).
Forum time: Saturday 00:32 UTC (Europe/Vienna)

The way to do research is to attack the facts
at the point of greatest astonishment.    Celia Green

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