If the reference product does not pass in BCS ?? [Dissolution / BCS / IVIVC]

posted by ElMaestro  – Denmark, 2018-01-09 06:35 (2354 d 13:18 ago) – Posting: # 18151
Views: 3,910

Hi MS,

❝ How can I proceed with a biowaiver if the reference product does not pass in all conditions of dissolution required to BCS?


How about Mahalanobis or Bootstrap?

Pass or fail!
ElMaestro

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