What is the point of IVIVCs for generics? [Dissolution / BCS / IVIVC]

posted by jag009  – NJ, 2016-04-20 23:29 (3217 d 22:18 ago) – Posting: # 16228
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Hi Dr. Dan,

IVIVC is applicable for a generic company in terms formulation development, post pilot bio-study formulation optimization (ie: if established, the model allows you to predict a target disso profile which can result in a product BE to reference).

Of course then you have specification, site transfer, stability, yada yada...

John

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