in vivo data before tweaking in vitro [Dissolution / BCS / IVIVC]

posted by Helmut Homepage – Vienna, Austria, 2017-06-24 21:30 (3279 d 18:43 ago) – Posting: # 17501
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Hi Kiran,

a generic product must demonstrate BE in the rate (Cmax) and extent of absorption (AUC), right?
If your dissolution method is not predictive (you can’t tell before you have in vivo data!) any difference might – or might not – be relevant.
Run a small pilot study to get an idea. IMHO, it is a waste of time to first tweak the dissolution which possibly was overdiscriminatory.
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