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

posted by Mauricio Sampaio - Brazil, 2018-01-10 13:52  - Posting: # 18159
Views: 1,354

Hi El Maestro

» How about Mahalanobis or Bootstrap?

I understood that Mahalanobis and Bootstrap help to understand how the distance is not always what it seems. But, how these statistical tools could help me, if the reference product does not meets the minimum dissolution requirements to obtain a biowaiver of the test product?:confused:

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