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

posted by ElMaestro - Denmark, 2018-01-09 05:35  - Posting: # 18151
Views: 1,479

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?

if (3) 4

Best regards,
ElMaestro

"(...) targeted cancer therapies will benefit fewer than 2 percent of the cancer patients they’re aimed at. That reality is often lost on consumers, who are being fed a steady diet of winning anecdotes about miracle cures." New York Times (ed.), June 9, 2018.

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