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RegisterBCS class II problematic [Dissolution / BCS / IVIVC]
Hi Helmut!
I like when you give a reply! You understand exactly my problem! Recently I received a return saying that biowaiver to Ibuprofen is not applied! I know that FDA has the same recommendation to Ibuprofen 100 mg/ ml (20 mg/ ml), but according Orange Book there is just this strength in the market. Then, I think that is obvious that waiver is not applied!
Thank you again for you support!
I like when you give a reply! You understand exactly my problem! Recently I received a return saying that biowaiver to Ibuprofen is not applied! I know that FDA has the same recommendation to Ibuprofen 100 mg/ ml (20 mg/ ml), but according Orange Book there is just this strength in the market. Then, I think that is obvious that waiver is not applied!
Thank you again for you support!
Complete thread:
- Is applied biowaiver to lower strengths of suspension form Mauricio Sampaio 2013-07-24 03:45
![[Mix]](https://static.bebac.at/img/mix.png "open in Mix view")
- BCS class II problematic Helmut 2013-07-24 14:47
- BCS class II problematicMauricio Sampaio 2013-07-24 15:29
- BCS class II problematic Helmut 2013-07-24 14:47
Ing. Helmut Schütz