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RegisterBiowaiver salt vs. cocrystal [Dissolution / BCS / IVIVC]
Hi everybody
Biowaivers face a lot of rejection. Has anybody gained experience submitting a biowaiver request comparing a medicinal product containing the salt of an API against another medicinal product (same pharmaceutical form) with the co-crystal of the same API?
Looking forward to your valuable replies. Thanks in advance.
Biowaivers face a lot of rejection. Has anybody gained experience submitting a biowaiver request comparing a medicinal product containing the salt of an API against another medicinal product (same pharmaceutical form) with the co-crystal of the same API?
Looking forward to your valuable replies. Thanks in advance.
—
Kind regards and have a nice day
Dr_Dan
Kind regards and have a nice day
Dr_Dan
Complete thread:
- Biowaiver salt vs. cocrystalDr_Dan 2017-05-24 18:56 [Dissolution / BCS / IVIVC]
![[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. cocrystal nobody 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