Biowaiver only for BCS I and – under certain conditions – BCS III drugs [Dissolution / BCS / IVIVC]

posted by dshah – India/ United Kingdom, 2020-07-17 06:27 (431 d 10:44 ago) – Posting: # 21728
Views: 1,494

» » … is the end of the story.
»
» He is seeking additional strength biowaiver and not BCS based biowaiver. The story might not have ended after all....there should be a sequel somewhere.

Thank you everyone for your valuable suggestions!

Yes, I am seeking for additional strength biowaiver through in vitro dissolution testing.
Is there any alternative for media selection?
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?

Regards,
dshah

Complete thread:

Activity
 Admin contact
21,691 posts in 4,534 threads, 1,541 registered users;
online 14 (0 registered, 14 guests [including 4 identified bots]).
Forum time: Tuesday 17:12 CEST (Europe/Vienna)

“Data! Data! Data!” he cried impatiently.
“I can’t make bricks without clay!”    Arthur Conan Doyle

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