Susan
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2007-10-25 21:42

Posting: # 1255
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 Biowaivers [Dissolution / BCS / IVIVC]

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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