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RegisterWaiving of md study in MR combination product [Regulatives / Guidelines]
Dear all
For modified release products a multiple dose study is needed unless a single dose study has demonstrated that the mean AUC0-t after the first dose covers more than 90% (or 80%) of the mean AUCinf (no accumulation). If I have a combination product with an IR component and a MR component does the prerequisite for waiving the md study refers only to the MR component or do I have to show no accumulation also for the IR component?
Kind regards
Dan
For modified release products a multiple dose study is needed unless a single dose study has demonstrated that the mean AUC0-t after the first dose covers more than 90% (or 80%) of the mean AUCinf (no accumulation). If I have a combination product with an IR component and a MR component does the prerequisite for waiving the md study refers only to the MR component or do I have to show no accumulation also for the IR component?
Kind regards
Dan
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Kind regards and have a nice day
Dr_Dan
Kind regards and have a nice day
Dr_Dan
Complete thread:
- Waiving of md study in MR combination productDr_Dan 2013-09-11 14:42
![[Mix]](https://static.bebac.at/img/mix.png "open in Mix view")
- Still a draft! Helmut 2013-09-11 14:51
Ing. Helmut Schütz