Susan ● 2007-10-25 23:42 (5999 d 11:19 ago) Posting: # 1255 Views: 3,325 |
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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 |