Biowaivers [Dissolution / BCS / IVIVC]

posted by Susan – 2007-10-25 21:42  – Posting: # 1255
Views: 2,685

I am seeking clarification from experts on this 'BABE Forum' re. biowaivers.

In respect to an ANDA for a BCS Class I drug, is it possible to obtain a biowaiver without having to perform an initial full scale in vivo BE study? Or, as is my understanding, is a biowaiver only a possibility in subsequent (e.g. post SUPAC) applications?

Thanks,
Susan

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