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RegisterBCS Biowaiver for oral suspension [Dissolution / BCS / IVIVC]
Dear Mauricio,
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
❝ 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
Cheers,
Osama
Complete thread:
- BCS Biowaiver for oral suspension averroes1304 2018-11-19 21:14
![[Mix]](https://static.bebac.at/img/mix.png "open in Mix view")
- BCS Biowaiver for oral suspension Mauricio Sampaio 2018-11-23 15:39
- BCS Biowaiver for oral suspension wienui 2018-11-23 19:36
- BCS Biowaiver for oral suspension Mauricio Sampaio 2018-11-26 18:17
- BCS Biowaiver for oral suspensionwienui 2018-11-27 03:50
- BCS Biowaiver for oral suspension Mauricio Sampaio 2018-11-26 18:17
Ing. Helmut Schütz