Biowaiver [Dissolution / BCS / IVIVC]

posted by John Gray – 2008-06-19 08:36 (6577 d 11:37 ago) – Posting: # 1949
Views: 5,854
(edited on 2008-06-19 09:38)

You get a biowaiver if the ratio of the excipeints to the total weight of dosage forms are within the limits as per supac-IR or supac-MR (if urs is a extended release) upto level-1 and level-2.

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Edit: Full quote removed. Please see this post! [Ohlbe]

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