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Back to the forum  Query: 2018-01-20 00:14 CET (UTC+1h)
 

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

posted by ElMaestro - Denmark, 2018-01-09 05:35  - Posting: # 18151
Views: 262

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?

I could be wrong, but…


Best regards,
ElMaestro

"Moderation in moderation"

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