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RegisterProbably based on PK/PD modelling [Regulatives / Guidelines]
Thanks Mittyri,
Yes I see the merits of having partial AUC up to 12 hours for the products of interest in our discussion. What I fail to understand is why only Metadate CD has AUC7-t and AUC8-t while all other methylphenidate bi-release ER products (Concerta, Ritalin LA, Aptensio, Focalin XR) use partial AUCs up to 12 hours.
Have a look at the profiles of various Methylphenidate products (ok we are looking at mean plots). All profiles show more or less similar blood levels at >=12 hours and after.
![[image]](http://www.medscape.com/content/2003/00/46/27/462703/art-pharm462703.fig6.gif)
Oh well, like Helmut wrote "citizen's petition"
John
Yes I see the merits of having partial AUC up to 12 hours for the products of interest in our discussion. What I fail to understand is why only Metadate CD has AUC7-t and AUC8-t while all other methylphenidate bi-release ER products (Concerta, Ritalin LA, Aptensio, Focalin XR) use partial AUCs up to 12 hours.
Have a look at the profiles of various Methylphenidate products (ok we are looking at mean plots). All profiles show more or less similar blood levels at >=12 hours and after.
Oh well, like Helmut wrote "citizen's petition"
John
Complete thread:
- New Guidance - Methylphenidate jag009 2016-02-02 20:16 [Regulatives / Guidelines]
![[Mix]](https://static.bebac.at/img/mix.png "open in Mix view")
- New Guidance - Methylphenidate Helmut 2016-02-03 14:10
- New Guidance - Methylphenidate jag009 2016-02-03 22:53
- Probably based on PK/PD modelling mittyri 2016-02-04 23:35
- Probably based on PK/PD modellingjag009 2016-02-05 23:00
- New Guidance - Methylphenidate Helmut 2016-02-03 14:10
Ing. Helmut Schütz