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RegisterBiowaiver salt vs. cocrystal [Dissolution / BCS / IVIVC]
Hi again!
For one second assume your "cocrystal" is a different salt according to EMA guide. REF and cocrystal both Class 1? If the answer is no: End of story.
(Guess this is applicable here, as in many other cases, due to lack of data).
If yes: Go with sufficient details for a SA and ask as one question if your cocrystal is a different "salt" for the authority when it comes to a BCS biowaiver. But be prepared to get an answer as like trying to "den Pudding an die Wand nageln...".
If your sponsor is interested in timelines, he will do the BE-study and go on, I guess.
For one second assume your "cocrystal" is a different salt according to EMA guide. REF and cocrystal both Class 1? If the answer is no: End of story.
(Guess this is applicable here, as in many other cases, due to lack of data).If yes: Go with sufficient details for a SA and ask as one question if your cocrystal is a different "salt" for the authority when it comes to a BCS biowaiver. But be prepared to get an answer as like trying to "den Pudding an die Wand nageln...".
If your sponsor is interested in timelines, he will do the BE-study and go on, I guess.
—
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. cocrystal nobody 2017-05-24 20:21
- Biowaiver salt vs. cocrystal Dr_Dan 2017-05-29 09:16
- Biowaiver salt vs. cocrystalnobody 2017-05-29 10:15
- Biowaiver salt vs. cocrystal Dr_Dan 2017-05-29 09:16
- Biowaiver salt vs. cocrystal nobody 2017-05-24 20:21
Ing. Helmut Schütz