Literature reported Permeability Studies Accepted? [Dissolution / BCS / IVIVC]

posted by sameep – India, 2017-12-28 12:10 (1915 d 04:55 ago) – Posting: # 18110
Views: 3,980

Hi All,

Are permeability studies reported in literature (like absolute bioavailability >85%) acceptable for establishing BCS class I and apply for BCS Biowaiver (ANDA)? or we have to reinvent the Universe?


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