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RegisterControlled release Product [Dissolution / BCS / IVIVC]
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
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
Complete thread:
- Controlled release Productvatsalasinha 2009-03-19 11:26
![[Mix]](https://static.bebac.at/img/mix.png "open in Mix view")
- Controlled release Product kaushalesh 2009-09-18 10:17
Ing. Helmut Schütz