New Guidance - Methylphenidate [Regulatives / Guidelines]
Hi Helmut,
What I don't get it why 7-t for metadate CD whereas every other product is 7-12.. Okay citizen's petition... Look at PK profile of Aptensio XR, which has peaks at 2 hr and 8 hr
Aptensio XR
![[image]](http://www.aptensioxr.com/hcp/img/about/plasma-concentration-sm.png)
Ritalin LA.
![[image]](http://medlibrary.org/lib/images-rx/ritalin-la-1/ritalin-la-04.jpg)
Shouldn't Aptenio have 7-t as well for partial AUC since blood level is significantly high at the back due to the late release of the 2nd component?
John
P.S. I highly doubt that you will see subxform interaction test for the other ADHD dual release products other than Concerta...
What I don't get it why 7-t for metadate CD whereas every other product is 7-12.. Okay citizen's petition... Look at PK profile of Aptensio XR, which has peaks at 2 hr and 8 hr
Aptensio XR
![[image]](http://www.aptensioxr.com/hcp/img/about/plasma-concentration-sm.png)
Ritalin LA.
![[image]](http://medlibrary.org/lib/images-rx/ritalin-la-1/ritalin-la-04.jpg)
Shouldn't Aptenio have 7-t as well for partial AUC since blood level is significantly high at the back due to the late release of the 2nd component?
John
P.S. I highly doubt that you will see subxform interaction test for the other ADHD dual release products other than Concerta...
Complete thread:
- New Guidance - Methylphenidate jag009 2016-02-02 20:16
- New Guidance - Methylphenidate Helmut 2016-02-03 14:10
- New Guidance - Methylphenidatejag009 2016-02-03 22:53
- Probably based on PK/PD modelling mittyri 2016-02-04 23:35
- Probably based on PK/PD modelling jag009 2016-02-05 23:00
- New Guidance - Methylphenidate Helmut 2016-02-03 14:10
