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RegisterControlled release Product [Dissolution / BCS / IVIVC]
Dear Vatsala
Multi media dissolution is required for the regulatory submissions, but one can go for the BE study if dissolution is comparable in the discriminatory media. (provided that there is nop safety concerns like dose dumping). Anyway it depends upon the firms internal policy, whether they are ready to go for the BE study with this much level of confidence, (factor in the cost involved)
Regards
Kaushalesh
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Edit: Full quote removed. Please delete anything from the text of the original poster which is not necessary in understanding your answer; see also this post! [Jaime]
Multi media dissolution is required for the regulatory submissions, but one can go for the BE study if dissolution is comparable in the discriminatory media. (provided that there is nop safety concerns like dose dumping). Anyway it depends upon the firms internal policy, whether they are ready to go for the BE study with this much level of confidence, (factor in the cost involved)
Regards
Kaushalesh
--
Edit: Full quote removed. Please delete anything from the text of the original poster which is not necessary in understanding your answer; see also this post! [Jaime]
Complete thread:
- Controlled release Product vatsalasinha 2009-03-19 11:26
![[Mix]](https://static.bebac.at/img/mix.png "open in Mix view")
- Controlled release Productkaushalesh 2009-09-18 10:17
Ing. Helmut Schütz