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RegisterBio-waiver for Pregabalin Capsules [Dissolution / BCS / IVIVC]
Dear Samaya
In few cases FDA has not at all accepted the published literature information (even the Clinical Pharmacology and biopharmaceutics data of Inovator) so one need to be very cautious about that.
Also if the product/molecule is highly variable, FDA will ask you to do a BE study.
But in general for Pregabalin, these shall not be the concern!!
Hope this will help.
❝ 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.
In few cases FDA has not at all accepted the published literature information (even the Clinical Pharmacology and biopharmaceutics data of Inovator) so one need to be very cautious about that.
Also if the product/molecule is highly variable, FDA will ask you to do a BE study.
But in general for Pregabalin, these shall not be the concern!!
Hope this will help.
—
~A happy Soul~
~A happy Soul~
Complete thread:
- Bio-waiver for Pregabalin Capsules Anand 2015-03-11 11:38 [Dissolution / BCS / IVIVC]
![[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 Capsules Samaya B 2015-03-12 13:15
- Bio-waiver for Pregabalin Capsulesluvblooms 2015-03-13 09:18
- Bio-waiver for Pregabalin Capsules Maitri 2017-11-16 11:41
- Bio-waiver for Pregabalin Capsulesluvblooms 2015-03-13 09:18
- Bio-waiver for Pregabalin Capsules Samaya 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
Ing. Helmut Schütz