Bioequivalence and Bioavailability Forum • If the reference product does not pass in BCS ??

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

posted by ElMaestro – Denmark, 2018-01-09 06:35 (2292 d 20:49 ago) – Posting: # 18151
Views: 3,670

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?

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Pass or fail!
ElMaestro

If the reference product does not pass in BCS ?? Mauricio Sampaio 2018-01-08 19:59
- If the reference product does not pass in BCS ??ElMaestro 2018-01-09 05:35
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  - If the reference product does not pass in BCS ?? Mauricio Sampaio 2018-01-10 13:59