Controlled release Product [Dissolution / BCS / IVIVC]

posted by vatsalasinha – 2009-03-19 12:26 (6302 d 05:05 ago) – Posting: # 3379
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Dear Friends,

If there is a generic controlled/ extended release tablet for which we have to conduct a BA study, then as per the guidelines do we have to do a comparative dissolution of both test (Tablet)and reference (capsule) at pH 1.2, 4.5 and 6.8 before starting with the BA study? if the data is available only for pH 6.8 then should we do a comparative dissolution with the rest of the pH i.e. 1.2 and 4.5 also before starting the BA study?

Thanks and Regards

Dr.Vatsala Sinha

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