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RegisterComparative BA study vs Biowaiver for BCS I [Dissolution / BCS / IVIVC]
Dear Helmut,
That was the first impression. Thanks for confirming.
So, its better to conduct a comparative bioavailability study for BCS I, rather than biowaiver approach.
❝ Given that, for an ANDA I would say you have to re-invent the wheel.
That was the first impression. Thanks for confirming.
So, its better to conduct a comparative bioavailability study for BCS I, rather than biowaiver approach.
Complete thread:
- Disturbing wording ElMaestro 2017-12-25 18:28 [Dissolution / BCS / IVIVC]
![[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 Isameep 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