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
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