permeability testing and biowaiver [Dissolution / BCS / IVIVC]

posted by jag009  – NJ, 2012-04-30 22:08 (5161 d 13:53 ago) – Posting: # 8482
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Also make sure the Innovator IR product meets the in-vitro release spec that is suggested by the FDA guidance. Something like NLT 85% dissolved in 15 mins, otherwise you can't file a BCS class 1 biowaiver.

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