Susan
●    

2007-10-25 23:42
(6805 d 18:22 ago)

Posting: # 1255
Views: 4,520
 

 Biowaivers [Dissolution / BCS / IVIVC]

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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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