BCS Biowaiver for oral suspension [Dissolution / BCS / IVIVC]

posted by wienui  – Germany/Oman, 2018-11-27 03:50 (1272 d 04:38 ago) – Posting: # 19653
Views: 3,734

(edited by wienui on 2018-11-28 03:01)

Dear Mauricio,

» Why not? The article ( https://www.ncbi.nlm.nih.gov/pubmed/29382433) does't explain the reason! Do you know?

There are a lot of differences between the global jurisdictions, some of them referred to different scientific opinions ( which I can accept it) on the other hand a lot of them you can't find any scientific reasons behind at all. Guidelines ( Guidances) are made from Human, who are different and harmoni(s)zation will still be not achievable dream.
Plz. s. this post from Helmut, https://forum.bebac.at/mix_entry.php?id=12529#p12535.

I'm myself inclined to the Pro- waiving of semisolid dosage form.

Best regards,
Osama

Cheers,
Osama

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