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RegisterLiterature reported Permeability Studies Accepted? [Dissolution / BCS / IVIVC]
Hi All,
Are permeability studies reported in literature (like absolute bioavailability >85%) acceptable for establishing BCS class I and apply for BCS Biowaiver (ANDA)? or we have to reinvent the Universe?
Regards,
Sameep.
Are permeability studies reported in literature (like absolute bioavailability >85%) acceptable for establishing BCS class I and apply for BCS Biowaiver (ANDA)? or we have to reinvent the Universe?
Regards,
Sameep.
Complete thread:
- Disturbing wording ElMaestro 2017-12-25 18:28
![[Mix]](https://static.bebac.at/img/mix.png "open in Mix view")
- Disturbing wording Helmut 2017-12-26 13:14
- Literature reported Permeability Studies Accepted?sameep 2017-12-28 11:10
- Reliable source, sufficient number of subjects Helmut 2017-12-28 12:17
- Comparative BA study vs Biowaiver for BCS I sameep 2018-01-02 09:35
- Reliable source, sufficient number of subjects Helmut 2017-12-28 12:17
- Literature reported Permeability Studies Accepted?sameep 2017-12-28 11:10
- Disturbing wording Helmut 2017-12-26 13:14
Ing. Helmut Schütz