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

posted by dshah  – India/United Kingdom, 2020-07-17 08:27 (866 d 12:00 ago) – Posting: # 21728
Views: 2,248

❝ ❝ … 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

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