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RegisterBiowaiver salt vs. cocrystal [Dissolution / BCS / IVIVC]
Hi Doc!
Talking about EU? And BCS-based biowaivers?
The EU Guideline is crystal clear, for different salts: Both have to be BCS-class I.
Do you have all data necessary to prove? Otherwise, maybe a waste of time. That's why biowaivers are not so easy, in my opinion, you need some (non-standard) data like solubility over pH (and at pKa) and maybe some permeability data not at hand (at sufficient detail) for generics from published literature...
I think often people go the "known" way, BE-study, end of game. Instead of investing time (!) and money for a task with unknown outcome. On the other hand, if you have enough data before going for a SA you might be able to convince authorities.
Edit: Please don’t shout! [Helmut]
Talking about EU? And BCS-based biowaivers?
The EU Guideline is crystal clear, for different salts: Both have to be BCS-class I.
Do you have all data necessary to prove? Otherwise, maybe a waste of time. That's why biowaivers are not so easy, in my opinion, you need some (non-standard) data like solubility over pH (and at pKa) and maybe some permeability data not at hand (at sufficient detail) for generics from published literature...
I think often people go the "known" way, BE-study, end of game. Instead of investing time (!) and money for a task with unknown outcome. On the other hand, if you have enough data before going for a SA you might be able to convince authorities.
Edit: Please don’t shout! [Helmut]
—
Kindest regards, nobody
Kindest regards, nobody
Complete thread:
- Biowaiver salt vs. cocrystal Dr_Dan 2017-05-24 18:56
![[Mix]](https://static.bebac.at/img/mix.png "open in Mix view")
- Biowaiver salt vs. cocrystalnobody 2017-05-24 20:21
- Biowaiver salt vs. cocrystal Dr_Dan 2017-05-29 09:16
- Biowaiver salt vs. cocrystal nobody 2017-05-29 10:15
- Biowaiver salt vs. cocrystal Dr_Dan 2017-05-29 09:16
- Biowaiver salt vs. cocrystalnobody 2017-05-24 20:21
Ing. Helmut Schütz