Additional Strength Biowaiver Requirements [Dissolution / BCS / IVIVC]

posted by Obinoscopy  – USA, 2020-07-18 05:13 (1792 d 23:34 ago) – Posting: # 21738
Views: 5,208

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:

UA Flag
Activity
 Admin contact
23,424 posts in 4,927 threads, 1,672 registered users;
10 visitors (0 registered, 10 guests [including 9 identified bots]).
Forum time: 04:47 CEST (Europe/Vienna)

To call the statistician after the experiment is done
may be no more than asking him to perform a postmortem examination:
he may be able to say what the experiment died of.    R.A. Fisher

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