Biowaiver for Nasal Sprays [Dissolution / BCS / IVIVC]

posted by ElMaestro  – Denmark, 2014-06-06 02:33 (4401 d 10:06 ago) – Posting: # 13034
Views: 5,082

Hi Mauricio,

❝ Which in vitro tests are needed to biowaiver for Nasal Sprays of other strenghts when bioequivalence is accepted to one strenght? I am considering a PK study.


Where do you intend to submit? Did you enter a dialogue with regulators? Are we talking mometasone? Did you compare particle size distribution profiles?
—
Pass or fail!
ElMaestro

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