Biowaiver [Dissolution / BCS / IVIVC]
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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Edit: Full quote removed. Please see this post! [Ohlbe]
Complete thread:
- Biowaiver BEAZ 2008-06-13 12:56
- BiowaiverJohn Gray 2008-06-19 06:36