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permeability testing and biowaiver [Dissolution / BCS / IVIVC]

posted by jag009 – NJ, 2012-04-30 22:08 (5155 d 08:57 ago) – Posting: # 8482
Views: 5,225

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.

Complete thread:

permeability testing and biowaiver Compliance 2012-04-28 13:13 [Dissolution / BCS / IVIVC]
- permeability testing and biowaiver drgunasakaran1 2012-04-30 07:09
- permeability testing and biowaiver Dr_Dan 2012-04-30 14:13
- permeability testing and biowaiverjag009 2012-04-30 20:08

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