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RegisterBio-waiver for Pregabalin Capsules [Dissolution / BCS / IVIVC]
Dear Anand,
In my opinion, Literature reference for permeability in terms of caco 2 cell permeability values should be acceptable to FDA.
If this value is not directly available, you can define high permeability using absolute bioavailability, rapid and complete absorption after oral administartion, mass balance data / % of unchanged drug recovered, wide therapeutic window for said drug.
Hope this would be helpful.
Regards,
Samaya.
In my opinion, Literature reference for permeability in terms of caco 2 cell permeability values should be acceptable to FDA.
If this value is not directly available, you can define high permeability using absolute bioavailability, rapid and complete absorption after oral administartion, mass balance data / % of unchanged drug recovered, wide therapeutic window for said drug.
Hope this would be helpful.
Regards,
Samaya.
Complete thread:
- Bio-waiver for Pregabalin Capsules Anand 2015-03-11 11:38
![[Mix]](https://static.bebac.at/img/mix.png "open in Mix view")
- Bio-waiver for Pregabalin Capsules Tina 2015-03-11 17:27
- Bio-waiver for Pregabalin CapsulesSamaya B 2015-03-12 13:15
- Bio-waiver for Pregabalin Capsules luvblooms 2015-03-13 09:18
- Bio-waiver for Pregabalin Capsules Maitri 2017-11-16 11:41
- Bio-waiver for Pregabalin Capsules luvblooms 2015-03-13 09:18
- Bio-waiver for Pregabalin CapsulesSamaya B 2015-03-12 13:15
- Bio-waiver for Pregabalin Capsules Dr_Dan 2015-03-12 13:49
- Bio-waiver for Pregabalin Capsules Tina 2015-03-11 17:27
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