Please do your homework first [Dissolution / BCS / IVIVC]

posted by Helmut Homepage – Vienna, Austria, 2019-11-24 10:51 (311 d 15:25 ago) – Posting: # 20864
Views: 1,277

Hi AB,

» Whether USFDA accept our proposal without permeability study data ?

No way – and for good reasons. Though the drug is highly soluble, you don’t know whether it is in class 1 or 3 (Guidance Sections III.B. and VII.B.). Biowaivers for class 3 drugs are acceptable only if fulfilling certain conditions.

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Helmut Schütz
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