Statistical comparison of dissolution profiles - variable nr of units [Dissolution / BCS / IVIVC]

posted by ElMaestro  – Denmark, 2019-07-17 23:02 (2184 d 00:24 ago) – Posting: # 20384
Views: 3,998

Hi MSimoes,

❝ I don't think we should "choose" ou "not consider" some of the results, but then we are in a grey zone in the regulatory area. Is this comparison (18 vs 12 units, or other!) acceptable for f2, bootstrap f2 and MSD? What is your experience?


That should generally be ok, in my experience.
—
Pass or fail!
ElMaestro

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