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

posted by Mauricio Sampaio  – Brazil, 2018-01-08 20:59 (2382 d 05:03 ago) – Posting: # 18150
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How can I proceed with a biowaiver if the reference product does not pass in all conditions of dissolution required to BCS?

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