Dissolution [Dissolution / BCS / IVIVC]

posted by jag009  – NJ, 2014-08-22 18:47 (3893 d 15:42 ago) – Posting: # 13419
Views: 9,190

Guys and Girls,

A question... Suppose you have an IR drug product which is highly soluble but poor in permeability and has a Tmax of 8 hrs. Do you think slowing down the rate of in-vitro release will affect the overall PK?

Assume this scenario...
Under the same dissolution medium, assuming the reference is releasing no less than 80% at 30 mins, and your product is releasing no less than 80% at 60 mins. What do you think?

Thanks
John

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