Biowaiver salt vs. cocrystal [Dissolution / BCS / IVIVC]

posted by Dr_Dan  – Germany, 2017-05-24 20:56 (2968 d 22:10 ago) – Posting: # 17406
Views: 5,650

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.
—
Kind regards and have a nice day
Dr_Dan

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