Dissolution profile comparison with one dissolution medium [Dissolution / BCS / IVIVC]

posted by Ionsource – Pakistan, 2015-05-08 11:15 (4064 d 18:36 ago) – Posting: # 14774
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Hi all,

I have recently seen a protocol for dissolution profile comparison where only one dissolution medium was used that was mentioned in Pharmacopoeial monograph of the product and samples were collected at multiple time points.

The manufacturer's intention is to proceed for BE study on the basis of the results obtained from this dissolution test.

I wonder if it is the right practice.

Please comment.

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