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Registerpermeability testing and biowaiver [Dissolution / BCS / IVIVC]
Dear compliance
Regulatory authorities still have some problems with biowaivers, especially if you provide in vitro data on permeability. Then you have to face a lot of questions. The demonstration of complete absorption in humans is preferred for BCS-based biowaiver applications. In most cases you will find information on permeability in scientific literature. If you are lucky it is mentioned in the originatorś SmPC or in the EPAR, then it can be regarded as public (approved) knowledge. Complete absorption is considered to be established where measured extent of absorption is ≥ 85 %. Complete absorption is generally related to high permeability.
I hope this helps.
Kind regards
Dan
Regulatory authorities still have some problems with biowaivers, especially if you provide in vitro data on permeability. Then you have to face a lot of questions. The demonstration of complete absorption in humans is preferred for BCS-based biowaiver applications. In most cases you will find information on permeability in scientific literature. If you are lucky it is mentioned in the originatorś SmPC or in the EPAR, then it can be regarded as public (approved) knowledge. Complete absorption is considered to be established where measured extent of absorption is ≥ 85 %. Complete absorption is generally related to high permeability.
I hope this helps.
Kind regards
Dan
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Kind regards and have a nice day
Dr_Dan
Kind regards and have a nice day
Dr_Dan
Complete thread:
- permeability testing and biowaiver Compliance 2012-04-28 13:13
![[Mix]](https://static.bebac.at/img/mix.png "open in Mix view")
- permeability testing and biowaiver drgunasakaran1 2012-04-30 07:09
- permeability testing and biowaiverDr_Dan 2012-04-30 14:13
- permeability testing and biowaiver jag009 2012-04-30 20:08
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